Marina V Shabalow, Moya L Alfonso, Dana S Mills, Nathaniel L Holzman
{"title":"Lymphedema therapy and wound healing: a retrospective analysis of pretreatment and posttreatment wound volume.","authors":"Marina V Shabalow, Moya L Alfonso, Dana S Mills, Nathaniel L Holzman","doi":"10.25270/wnds/25098","DOIUrl":"https://doi.org/10.25270/wnds/25098","url":null,"abstract":"<p><strong>Background: </strong>Venous leg ulcers (VLUs) frequently exhibit prolonged healing times, particularly in the presence of lower extremity lymphedema. One approach to managing VLU is to combine traditional wound care with lymphedema therapy (LT). Despite recognition of compression as an effective agent for management of chronic wounds, use of lymphedema services remains insufficient among health care providers.</p><p><strong>Objective: </strong>To investigate the effectiveness of LT for tissue repair and examine the effect of various factors on wound healing.</p><p><strong>Materials and methods: </strong>Electronic medical records of patients with VLU who completed LT between June 2016 and March 2020 were reviewed. Wound volume (length × width × depth) was compared before and after LT, and medians of nonnormally distributed data were compared via the Wilcoxon signed rank test. Demographic characteristics and medical history were evaluated to determine their relationship to VLU healing. A 3-step hierarchical approach was used to investigate the effect of various factors on predicting tissue repair.</p><p><strong>Results: </strong>A total of 178 wounds in 115 patients were included in the analysis. The average wound volume before LT was 14.4 cm³. After lymphedema intervention, the mean wound volume decreased to 3.8 cm³, a significant reduction in wound size (P < .001). A hierarchical regression model revealed no statistically significant relationships between wound closure and age, sex, comorbidities, or treatment-related factors. However, body mass index emerged as a moderately significant predictor of wound healing (P = .013).</p><p><strong>Conclusion: </strong>The findings support the effectiveness of LT for healing chronic VLU in patients with lymphedema treated in an outpatient clinic.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 9","pages":"237-246"},"PeriodicalIF":1.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149184555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Bradford, Jill de Grood, Kathryn Ambler, Negar Dehghan Noudeha, Patty Wickson, Chester Ho
{"title":"Prospective evaluation of the clinical effectiveness of an innovative catalytic wound care technology.","authors":"Anna Bradford, Jill de Grood, Kathryn Ambler, Negar Dehghan Noudeha, Patty Wickson, Chester Ho","doi":"10.25270/wnds/25122","DOIUrl":"10.25270/wnds/25122","url":null,"abstract":"<p><strong>Background: </strong>Chronic wounds present a significant health concern due to their prolonged healing time, risk of severe complications, and the burden they place on patients, health care providers, and the health system.</p><p><strong>Objective: </strong>To prospectively evaluate an advanced wound care treatment that delivers catalytic technology (through polymers engineered to replicate the extracellular matrix) and facilitates copper-dependent cellular signaling pathways involved in wound healing.</p><p><strong>Methods: </strong>This interrupted time series was a multisite, within-patient controlled, clinical evaluation of the catalytic technology involving 25 participants each with at least 1 chronic wound (pressure injury, diabetic foot ulcer, or venous leg ulcer). Participants received standard wound care for 28 days (control phase), followed by 28 days with the catalytic technology replacing the primary dressing (intervention phase). Wound percent area reduction (PAR) was assessed weekly.</p><p><strong>Results: </strong>The average wound age prior to study inclusion was 84 weeks. In the control phase, the average PAR was -1.0%. In the intervention phase, the average PAR was 56.6%, showing that the catalytic technology accelerated wound healing (total overall change, 57.6%; P < .0001; > 95% power). The catalytic technology also demonstrated a safety profile equivalent to that of current state dressings.</p><p><strong>Conclusion: </strong>When used in combination with standard of care practices to promote wound healing, the catalytic technology was shown to be an effective tool in the treatment of chronic wounds compared with other available wound dressings.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 9","pages":"224-236"},"PeriodicalIF":1.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149184561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
William Tettelbach, Julie Schottenstein, Mohanad Eltahir, Mario Cala, Juliette Perez, Fadi Jaafar, Brian Gillette, Paul Fawson
{"title":"Healing outcomes after placental membrane-based skin substitute allografts in multiple wound types in routine care: a retrospective case series from a prospective observational wound registry.","authors":"William Tettelbach, Julie Schottenstein, Mohanad Eltahir, Mario Cala, Juliette Perez, Fadi Jaafar, Brian Gillette, Paul Fawson","doi":"10.25270/wnds/25138","DOIUrl":"10.25270/wnds/25138","url":null,"abstract":"<p><strong>Background: </strong>Real-world data on cellular, acellular, and matrix-like products (CAMPs) remain limited, particularly in mixed-etiology cohorts.</p><p><strong>Objective: </strong>To describe routine practice hard-to-heal wound healing outcomes among adults treated with placental membrane-based allografts.</p><p><strong>Methods: </strong>This retrospective case series drew on a prospective observational wound registry. Eligible adults had at least 1 application of a placental-derived CAMP and 1 follow-up visit. One index wound per patient was selected for primary analyses; secondary summaries covered all wounds. The primary endpoint was complete closure by 12 weeks; secondary endpoints were time to closure, at least 50% area reduction at 4 weeks, and percentage area reduction (PAR) at 12 weeks among open wounds.</p><p><strong>Results: </strong>The cohort included 44 patients with 60 CAMP-treated wounds; 75.0% of index wounds were lower extremity diabetic ulcers (LEDUs), and median baseline duration was 91 days. Closure by 12 weeks occurred in 17 of 44 index wounds (38.6%; 95% CI, 24.4%-54.5%) and 22 of 60 wounds (36.7%; 95% CI, 24.6%-50.1%). Median time to closure among healed wounds was 28 days. At 4 weeks, 52.3% of index and 56.7% of all wounds achieved at least 50% area reduction. Among open wounds at 12 weeks, median PAR was 48.8% (index) and 50.8% (all). In a complete-case subset, 22 of 26 wounds closed (84.6%; 95% CI, 65.1%-95.6%), interpreted cautiously because wounds without ascertainable 12-week status were excluded.</p><p><strong>Conclusions: </strong>Findings in this cohort, most with LEDUs and substantial comorbidity burden, provide pragmatic benchmarks for CAMP-treated wounds and support the need for larger, standardized comparative studies.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 8","pages":"196-200"},"PeriodicalIF":1.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hongyu Wang, Lin Chen, Qian Gao, Guirong Shi, LiPing Jiang
{"title":"Infected wound in a lower extremity hematoma in a patient with thrombocytopenia after renal transplantation.","authors":"Hongyu Wang, Lin Chen, Qian Gao, Guirong Shi, LiPing Jiang","doi":"10.25270/wnds/24206","DOIUrl":"10.25270/wnds/24206","url":null,"abstract":"<p><strong>Background: </strong>Renal transplantation is a highly effective treatment for end-stage renal failure. However, prolonged administration of immunosuppressive agents is necessary, which may elevate the risk of infection, particularly in cases associated with injury. These medications have the potential to induce thrombocytopenia, which can complicate wound management, because mechanical debridement is contraindicated in such cases. The paucity of literature on infected hematoma following renal transplantation is striking.</p><p><strong>Case report: </strong>The case reported herein is that of a hematoma wound infection located on the skin of the lower extremity, which occurred as a result of a car accident that took place 20 years after renal transplantation. The patient had been experiencing thrombocytopenia due to prolonged immunosuppressant therapy for 2 months prior to this incident. A combination of ultrasonic debridement and moist wound dressings was used for effective management of the infected wound.</p><p><strong>Conclusion: </strong>The successful use of ultrasonic debridement in conjunction with autolytic debridement can not only prevent bleeding during debridement but also effectively remove necrotic tissue, thereby promoting favorable wound healing and enabling patients to resume normal daily life.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 8","pages":"208-211"},"PeriodicalIF":1.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Colton C Mowers, Joe H Hilsman, Meera M Dhodapkar, Michael S Shuler, James Coleman Fleming, Mohamed Sarraj, Brett A Freedman, Michael S Shuler
{"title":"Performance of a novel negative pressure wound therapy filler in wound contraction.","authors":"Colton C Mowers, Joe H Hilsman, Meera M Dhodapkar, Michael S Shuler, James Coleman Fleming, Mohamed Sarraj, Brett A Freedman, Michael S Shuler","doi":"10.25270/wnds/26050","DOIUrl":"https://doi.org/10.25270/wnds/26050","url":null,"abstract":"<p><strong>Background: </strong>Negative pressure wound therapy promotes wound healing through fluid removal, edema reduction, and mechanical contraction. A novel thermoplastic elastomer (TPE) dressing has been developed to improve exudate evacuation and reduce tissue ingrowth, but its effect on wound contraction compared with reticulated open cell foam (ROCF) remains unclear.</p><p><strong>Objective: </strong>To compare the degree of wound contraction with the TPE dressing, ROCF, or no filler at different wound depths and negative pressure settings in a porcine explant model.</p><p><strong>Materials and methods: </strong>The effect of the materials or lack thereof on wound contraction was investigated at 2 wound depths (shallow, deep) and 3 negative pressure settings (-50 mm Hg, -80 mm Hg, and -125 mm Hg). Wound width was measured at 3 standardized locations before and during therapy. Univariable and multivariable linear regression analyses were performed to identify factors associated with contraction.</p><p><strong>Results: </strong>A total of 810 measurements were obtained. Both the TPE dressing and ROCF demonstrated statistically significantly greater contraction than no filler. In deep wounds, greater contraction was noted with the TPE dressing compared with ROCF. Higher negative pressure and increased wound depth were independently associated with greater contraction. Absolute differences in contraction between dressings were small (<3 mm across all conditions).</p><p><strong>Conclusion: </strong>The TPE dressing provides equivalent or greater wound contraction compared with ROCF, particularly in deep wounds, without impairing macrodeformation. Given the small magnitude of differences, the clinical relevance of this finding likely depends on additional factors, which should be evaluated in future in vivo studies.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 8","pages":"201-207"},"PeriodicalIF":1.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Martin Eduardo Morales-Saavedra, Esperanza Ramírez-Arano, Juan Carlos Bravo-Soriano, Eduardo Alfonso Hernández-Muñoz
{"title":"Use of negative pressure wound therapy as an occlusive dressing on a skin graft in a patient with hostile abdomen.","authors":"Martin Eduardo Morales-Saavedra, Esperanza Ramírez-Arano, Juan Carlos Bravo-Soriano, Eduardo Alfonso Hernández-Muñoz","doi":"10.25270/wnds/25082","DOIUrl":"10.25270/wnds/25082","url":null,"abstract":"<p><strong>Background: </strong>In hostile abdomen the abdominal cavity is exposed, with retracted edges compacted into a single block of fibrous tissue that does not allow for adequate dissection or separation. After the inflammation is controlled, definitive closure of the abdomen can be attempted. One closure technique includes the use of skin grafts, which requires an adequate recipient site. Several therapies are used to promote granulation, such as dressings, antiseptic solutions, and negative pressure wound therapy. However, there is limited evidence of the use of these therapies in a hostile abdomen.</p><p><strong>Case report: </strong>A patient with hostile abdomen eventually achieved closure after split-thickness and full-thickness skin grafting in conjunction with use of a lipidocolloidal dressing and negative pressure wound therapy. The findings are reported in line with the Surgical CAse REport criteria.</p><p><strong>Conclusion: </strong>Negative pressure wound therapy may improve the condition of the abdomen for receiving a skin graft. Successful use of a lipidocolloidal dressing as an interface between the graft and negative pressure wound therapy was achieved in this case. Effective and continuous communication among medical staff, the patient, and his relatives contributes to improved outcomes.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 8","pages":"212-217"},"PeriodicalIF":1.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy of autologous blood-derived therapies in diabetic foot ulcers: a systematic review and meta-analysis of randomized controlled trials.","authors":"Robert J Snyder, Martin Lee","doi":"10.25270/wnds/25085","DOIUrl":"10.25270/wnds/25085","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers (DFUs) are a significant complication of diabetes, leading to high morbidity rate, amputation, and health care costs. Autologous blood-derived products, including autologous whole blood clot (AWBC), platelet-rich plasma, and platelet-rich fibrin, have emerged as promising treatments that leverage the body's own healing mechanisms.</p><p><strong>Objective: </strong>To evaluate the efficacy of autologous blood-derived products compared with standard-of-care (SOC) treatment in achieving complete healing of DFUs by 12 weeks.</p><p><strong>Methods: </strong>A systematic review and meta-analysis of sources published through April 2025 was performed following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed, Embase, and the Cochrane Library were searched. Randomized controlled trials (RCTs) reporting complete healing at 12 weeks were included. Data were pooled using a random effects model to calculate odds ratio (OR) with 95% CI.</p><p><strong>Results: </strong>Six RCTs with a total of 629 patients met the inclusion criteria. Autologous blood-derived products significantly improved the odds of complete healing at 12 weeks compared with SOC (pooled OR, 2.24; 95% CI, 1.47-3.41; P = .0045). Among these products, AWBC demonstrated the highest efficacy, and there was minimal indication of publication bias.</p><p><strong>Conclusion: </strong>Autologous blood-derived products significantly improve healing outcomes in DFUs compared with SOC, supporting their clinical use. Further research should refine product preparation methods and treatment durations to maximize efficacy.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 7","pages":"184-190"},"PeriodicalIF":1.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Bradford, Jill de Grood, Kathryn Ambler, Negar Dehghan Noudeh, Patty Wickson, Chester Ho
{"title":"Retrospective evaluation of the clinical effectiveness of an innovative catalytic wound care technology.","authors":"Anna Bradford, Jill de Grood, Kathryn Ambler, Negar Dehghan Noudeh, Patty Wickson, Chester Ho","doi":"10.25270/wnds/25123","DOIUrl":"https://doi.org/10.25270/wnds/25123","url":null,"abstract":"<p><strong>Background: </strong>Chronic, nonhealing wounds have significant negative effects on both patients and the health system, including increased morbidity and mortality.</p><p><strong>Objective: </strong>To retrospectively examine the effect of an advanced wound care treatment that delivers catalytic technology to the affected area through polymers that mimic the extracellular matrix.</p><p><strong>Materials and methods: </strong>The proprietary catalytic treatment matrix (CTM) technology facilitates copper-dependent cellular signaling pathways within the wound healing process. Patients whose wounds were originally treated following standard wound care protocols and then subsequently transitioned to the catalytic technology (as determined by their physician), were recruited from a specialized outpatient wound care clinic in Calgary, Alberta, Canada. Data were collected from charts for 19 patients with a total of 26 chronic wounds (venous leg ulcers and diabetic foot ulcers). Following initiation of the catalytic technology, time to wound closure was tracked via percent area reduction, or for up to 16 weeks if wounds did not close.</p><p><strong>Results: </strong>The average age of the wounds prior to application of the CTM technology was 39 weeks. After transitioning to CTM technology, 81% of wounds closed within 16 weeks. Notably, 77% of the wounds closed within the first 8 weeks (±2 days) of initiating use. Overall, the average time to closure was 43 days (median, 35 days).</p><p><strong>Conclusion: </strong>CTM technology was shown to be an effective tool for improving time to closure of chronic wounds.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 6","pages":"178-183"},"PeriodicalIF":1.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Eugenio Fuentes Pérez Júnior, Maria Natália de Paulo Ferreira, Francisco Gleidson de Azevedo Gonçalves, Advi Catarina Barbachan Moraes, Ellen Marcia Peres, Eduardo de Oliveira Carrilho Padula, Antonio Marcos Tosoli Gomes, Livia Fajin de Mello, Ana Carolina Coelho-Oliveira, Ana Gabriellie Valério-Penha, Danúbia da Cunha de Sá-Caputo, Ariane da Silva Pires
{"title":"Use of natural extracts and oils in healing superficial diabetic foot ulcer.","authors":"Eugenio Fuentes Pérez Júnior, Maria Natália de Paulo Ferreira, Francisco Gleidson de Azevedo Gonçalves, Advi Catarina Barbachan Moraes, Ellen Marcia Peres, Eduardo de Oliveira Carrilho Padula, Antonio Marcos Tosoli Gomes, Livia Fajin de Mello, Ana Carolina Coelho-Oliveira, Ana Gabriellie Valério-Penha, Danúbia da Cunha de Sá-Caputo, Ariane da Silva Pires","doi":"10.25270/wnds/25080","DOIUrl":"https://doi.org/10.25270/wnds/25080","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers are common and serious complications of diabetes, and they are associated with infections, amputations, and high morbidity. Treatment requires effective strategies to promote healing and prevent recurrence. Compounds containing natural extracts and oils have been widely used to promote tissue repair.</p><p><strong>Objective: </strong>To describe the healing process of superficial diabetic foot ulcers in the absence of peripheral arterial disease and infection in individuals treated with a compound based on natural extracts and oils.</p><p><strong>Materials and methods: </strong>Between May 2024 and June 2024, a retrospective, documentary, and quantitative study evaluating the efficacy of a compound based on natural extracts and oils in healing superficial diabetic foot ulcers (in the absence of peripheral arterial disease and infection) was conducted at a nursing unit that specializes in clinical podiatry. Data were analyzed using simple descriptive statistics. The study received ethical approval.</p><p><strong>Results: </strong>The medical records of 9 participants with a total of 12 treated lesions were analyzed. There were 7 male and 2 female participants, with a mean patient age of 64 years. The superficial diabetic foot ulcers were mainly located in the metatarsal heads and hallux regions. Of the 12 lesions, 75% (n = 9) achieved complete healing, while 25% (n = 3) did not completely heal but did show improvement.</p><p><strong>Conclusion: </strong>The use of a compound based on natural extracts and oils in the treatment of superficial diabetic foot ulcers in the absence of peripheral arterial disease and infection resulted in favorable outcomes in the healing process, according to the validated assessment tool used, the pressure ulcer scale for healing (PUSH) score.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 7","pages":"191-195"},"PeriodicalIF":1.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Windy Cole, Mitch Sanders, Vickie Driver, Marissa Carter, Peggy Dotson, Caroline Fife, Sarah Griffiths Langbord, Francis James, Holly Korzendorfer, Maribel Henao, Alisha Oropallo, Joseph Rolley, Robert Snyder, Marjana Tomic-Canic, Zweli Tunyiswa, Howard Walthall
{"title":"Proposed addendum to the 2006 US Food and Drug Administration guidance on chronic cutaneous ulcers and burn wounds: recommendations from the Wound Care Collaborative Community.","authors":"Windy Cole, Mitch Sanders, Vickie Driver, Marissa Carter, Peggy Dotson, Caroline Fife, Sarah Griffiths Langbord, Francis James, Holly Korzendorfer, Maribel Henao, Alisha Oropallo, Joseph Rolley, Robert Snyder, Marjana Tomic-Canic, Zweli Tunyiswa, Howard Walthall","doi":"10.25270/wnds/25132","DOIUrl":"10.25270/wnds/25132","url":null,"abstract":"<p><p>The Wound Care Collaborative Community (WCCC) presents this proposed addendum to the 2006 US Food and Drug Administration (FDA) guidance for industry on chronic cutaneous ulcers and burn wounds, with this addendum reflecting nearly 2 decades of scientific and clinical progress. Key gaps in the original guidance have emerged with advances such as the Wound Reporting in Animal and Human Preclinical Studies (WRAHPS) reporting standards and the FDA Biomarker Qualification Program. This proposed addendum updates preclinical recommendations by emphasizing standardized bioassays for biologics, improved animal model selection using WRAHPS criteria, and acknowledgment that animal studies primarily assess safety rather than predict clinical efficacy. Clinical study design recommendations incorporate digital wound assessment technologies; standardized photographic documentation; expanded biomarker use; and innovative umbrella, basket, and platform trial designs to better address biological heterogeneity in chronic wounds. While reaffirming complete wound closure as the most clinically meaningful end point, the addendum also supports the development of validated alternative end points, including patient-reported outcomes. Additional updates include biofilm detection strategies, point of care diagnostic tools, and recognition of differences between clinical trial populations and real world patients. These evidence based recommendations aim to accelerate development of safe and effective wound care products while ensuring alignment with modern regulatory standards.</p>","PeriodicalId":23752,"journal":{"name":"Wounds : a compendium of clinical research and practice","volume":"38 6","pages":"155-165"},"PeriodicalIF":1.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148273195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}