Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05610865

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Chronic Diabetic Foot Ulcer of Right Foot Chronic Diabetic Ulcer of Left Foot Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Infection Diabetic Foot Ulcer Neuropathic Diabetic Neuropathies Endocrine System Diseases Foot Diseases Foot Ulcer Foot Ulcer Due to Type 1 Diabetes Mellitus Foot Ulcer Due to Type 2 Diabetes Mellitus Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)

Lahore, Punjab Province, 54550, Pakistan

Location status: Recruiting

Location contact

Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS

CONTACT

[email protected]

+92-300-8423139

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control; Standard-of-care management

Other

Patients will undergo conventional wound care management.

Only PRP injection

Biological

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

PRP + SVF injection

Biological

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 injection

Biological

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

Primary outcomes

  1. Interview and visual inspection of ulcers recovery rate

    Time frame: 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 outcomes

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

    Time frame: 3 months

    Change in wound size (cm2) will be determined

Study contacts

Contact information is provided by the study sponsor or research team.

Amna Arif, M.Phil.

CONTACT

[email protected]

+92-333-4161068

Azra Mehmood, PhD

CONTACT

[email protected]

+92-333-4107008

Sponsors and collaborators

Lead sponsor

University of the Punjab

Other

Collaborators

  • Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
  • Higher Education Commission (Pakistan)
  • Jinnah Burn and Reconstructive Surgery Centre, Lahore

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2022
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.