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

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.

Conditions

• 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

Interventions

OTHER

Control; Standard-of-care management

Patients will undergo conventional wound care management.

BIOLOGICAL

Only PRP injection

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

BIOLOGICAL

PRP + SVF injection

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.

BIOLOGICAL

PRP + ASCs injection

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

Sponsors & Collaborators

• Centre of Excellence in Molecular Biology, University of the Punjab, Lahore

  collaborator UNKNOWN

• Higher Education Commission (Pakistan)

  collaborator OTHER

• Jinnah Burn and Reconstructive Surgery Centre, Lahore

  collaborator OTHER_GOV

• University of the Punjab

  lead OTHER

Principal Investigators

• Azra Mehmood, PhD · Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore

• Sheikh Riazuddin, PhD · Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-20

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Pakistan

Study Locations