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

Phase 1RecruitingNCT05610865

University of the Punjab28 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

Control; Standard-of-care managementOTHER

Patients will undergo conventional wound care management.

Only PRP injectionBIOLOGICAL

Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.

PRP + SVF injectionBIOLOGICAL

Uncultured cells (SVF) along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

PRP + ASCs injectionBIOLOGICAL

Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Interview and visual inspection of ulcers recovery rate

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.

Time frame: 3 months

Secondary Outcomes

Percentages (%) of wound closure rate (with respect to time) will be assessed.

Change in wound size (cm2) will be determined