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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds

Conditions
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Diabetic Foot Ulcer, Diabetes Mellitus, Diabetic Foot, 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, Diabetes Complications, Chronic Diabetic Ulcer of Left Foot, Chronic Diabetic Foot Ulcer of Right Foot

Intervention / Treatment
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* Other: Control; Standard-of-care management
* Biological: Only PRP injection
* Biological: PRP + SVF injection
* Biological: PRP + ASCs injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control; Standard-of-care management<br>Saline dressing will be done as a routine care management. | Other: Control; Standard-of-care management<br>* Patients will undergo conventional wound care management.<br>|
| Experimental: Only PRP injection<br>Only PRP will be injected at the wound site. | Biological: Only PRP injection<br>* Only PRP injected / cm2 intradermally at the border zone & inside of wound surface bed.<br>|
| Experimental: PRP + SVF injection<br>SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells. | Biological: PRP + SVF injection<br>* 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.<br>|
| Experimental: PRP + ASCs injection<br>Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells. | Biological: PRP + ASCs injection<br>* Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone & inside of wound surface bed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages (%) of wound closure rate (with respect to time) will be assessed. | Change in wound size (cm2) will be determined | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stromal vascular fraction (SVF), Adipose derived stem cells (ASCs), Diabetic foot ulcer (DFU), Platelet rich plasma (PRP)