Intraoperative Cellular Reprogramming-Enhanced Skin Transplantation for Diabetic Foot Ulcers: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- healing rate
Study Overview
Brief Summary
Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.
Detailed Description
The primary objective of this study is to assess the effectiveness and safety of autologous skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group is better than the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •.Adults aged ≥18 years with type 1 or type 2 diabetes mellitus, diagnosed according to WHO criteria.
- •.Presence of a chronic diabetic foot ulcer located below the ankle, classified as Wagner grade 2-3, with a post-debridement area of 5-80 cm².
- •.Target ulcer present for ≥4 weeks and unhealed despite ≥4 weeks of standard wound care prior to randomization.
- •.HbA1c <12%, measured at screening or within 3 months prior to randomization.
- •.Any revascularization of the affected limb completed ≥4 weeks before randomization.
- •.Ability to provide written informed consent and comply with all study procedures and follow-up requirements.
Exclusion Criteria
- •.Active infection of the target ulcer requiring systemic antibiotics, or presence of non-removable necrosis, purulence, or sinus tracts.
- •.Significant peripheral arterial disease, defined as ABI <0.7 or >1.
- •.End-stage renal disease or eGFR <20 mL/min/1.73 m².
- •.Active malignancy, uncontrolled autoimmune disease, or current use of systemic immunosuppressive therapy.
- •.Hematologic disorders that may impair wound healing.
- •.HIV infection or active hepatitis.
- •.Revascularization of the affected limb planned or performed within 4 weeks prior to randomization.
- •.Participation in another interventional clinical trial within 3 months prior to randomization.
- •.Pregnancy, lactation, or intention to become pregnant during the study period.
- •.Any condition that, in the investigator's judgment, could impair informed consent, protocol compliance, patient safety, or data reliability.
Arms & Interventions
autologous skin cell
autologous skin cell with skin graft
Intervention: autologous skin cell (Device)
skin graft
split-thickness skin graft as control group
Intervention: skin graft (Procedure)
Outcomes
Primary Outcomes
healing rate
Time Frame: postsurgery week 2
Incidence of complete wound healing within 2 weeks, defined as epithelialization without drainage confirmed by blinded assessors.
Secondary Outcomes
- recurrent rate(postsurgery months 12)
Investigators
Hu Zhicheng
FirstSunYetSen
First Affiliated Hospital, Sun Yat-Sen University