Efficacy and safety of Qufushengji powder in patients with diabetic foot ulcers: study protocol for a parallel randomized controlled trial

Abstract

Background and objective: Qufushengji powder is a classical external medicine in Chongqing Orthopaedic Hospital of Traditional Chinese Medicine for surgical ulcer. This trial is designed to demonstrate the safety and efficacy of Qufushengji powder for treatment of diabetic foot ulcers. Participants and methods: This is a parallel randomized controlled trial, which will be conducted at Chongqing Orthopaedic Hospital of Traditional Chinese Medicine, China. The included patients with moderate to severe diabetic foot ulcers will be randomly divided into control group and intervention group. Patients in the control and intervention groups will be sterilely bandaged with Kangfuxin solution and applied gauze strips of Qufushengji powder based on conventional therapy. In the study execution time of each stage, patient recruitment began in June 2020. The analysis of primary outcome measure will be completed in July 2021, and the study will be finished in May 2022. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Chongqing Orthopedics Hospital of Traditional Chinese Medicine on May 24, 2019 (approval No. 2019-17). Outcome measures: Ulcer healing rate after 12 weeks of treatment is primary outcome measure. Secondary outcome measures include relief of local foot symptoms, functional recovery and adverse events. Discussion: Results of this trial will provide preliminary evidence for the use of Qufushengji powder in the clinical treatment of diabetic foot ulcers. Trial registration: This trial was registered in the Chinese Clinical Trial Registry on April 25, 2020 (registration number: ChiCTR2000032315).