Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

Phase 1

Recruiting

• Conditions: Diabetic Foot Ulcer; Diabetic Foot Infection; Diabetic Foot Ulcer Neuropathic; Foot Ulcer Due to Type 1 Diabetes Mellitus; Foot Ulcer Due to Type 2 Diabetes Mellitus; Foot Ulcer; Chronic Diabetic Ulcer of Left Foot; Diabetic Foot; Diabetes Complications; Chronic Diabetic Foot Ulcer of Right Foot
• Interventions: Other: Control; Standard-of-care management; Biological: Only PRP injection; Biological: PRP + ASCs injection; Biological: PRP + SVF injection

• Registration Number: NCT05610865
• Lead Sponsor: University of the Punjab

Brief Summary

The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.

Detailed Description

Under local or general anesthesia, autologous fat will be harvested by using a manual aspiration or syringe-assisted technique. SVF and ASCs isolation from autologous lipoaspirates will be done by enzymatic digestion method (collagenase Type-1 solution for 45 minutes at 37°C). Cell quality assessment will be done prior to transplantation by trypan blue exclusion assay and total populations and fractions of cells identified by immunocytochemistry / flow cytometry. PRP will be derived by centrifugation from 50-100ml blood collected in anticoagulant carrying bag, from patient at the day of transplantation. The injection volume will depend on the wound area of each patient. 2 million cells/ 0.5 ml PRP will be mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Study Timeline

• Study Start: 2020-11-20
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Type 1 or Type 2 Diabetes Mellitus
• Age 20-60 years (Male/Female)
• Body mass index 20-30 kg/m2
• Suitable for liposuction
• Condition or Disease: Diabetic Neuropathy
• Wound Type: Chronic foot ulcer
• Approx. wound area: 2 cm2 - 8 cm2
• Wound Condition should be of Wagner's grade I (Limited to soft tissue)
• Duration of wound persistence: 6-24 Weeks
• Transcutaneous oxygen pressure > 30 mmHg, and an ankle brachial pressure index > 0.5.
• Already following an adequate off-loading method
• Provided signed informed consent

Exclusion Criteria

• Uncontrolled hyperglycemia (HbAlc > 9%)
• Presence of severe clinical sign of infection
• Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.
• Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases
• Patients with critical limb ischemia and osteomylitis
• Withdrawal of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control; Standard-of-care management	Control; Standard-of-care management	Saline dressing will be done as a routine care management.
Only PRP injection	Only PRP injection	Only PRP will be injected at the wound site.
PRP + ASCs injection	PRP + ASCs injection	Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.
PRP + SVF injection	PRP + SVF injection	SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.

Primary Outcome Measures

Name	Time	Method
Interview and visual inspection of ulcers recovery rate	3 months	This will be done in terms of diameter (cm2) of wounds, monitored in both cell transplanted and standard care patients after week interval till 3 months.

Secondary Outcome Measures

Name	Time	Method
Percentages (%) of wound closure rate (with respect to time) will be assessed.	3 months	Change in wound size (cm2) will be determined

Trial Locations

Locations (1)

Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC); 🇵🇰 Lahore, Punjab, Pakistan