Actively Recruiting

Phase 1
Age: 20Years - 60Years
All Genders
NCT05610865

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

Led by University of the Punjab · Updated on 2024-12-31

28

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

Sponsors

U

University of the Punjab

Lead Sponsor

C

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Type 1 or Type 2 Diabetes Mellitus
  • Age between 20 and 60 years (male or female)
  • Body mass index between 20 and 30 kg/m2
  • Suitable candidate for liposuction
  • Diagnosis of diabetic neuropathy
  • Presence of chronic foot ulcer
  • Wound area approximately 2 cm2 to 8 cm2
  • Wound limited to soft tissue, Wagner's grade I
  • Wound duration between 6 and 24 weeks
  • Transcutaneous oxygen pressure greater than 30 mmHg
  • Ankle brachial pressure index greater than 0.5
  • Already following an adequate off-loading method
  • Provided signed informed consent
Not Eligible

You will not qualify if you...

  • Uncontrolled high blood sugar (HbA1c greater than 9%)
  • Severe clinical signs of infection
  • Unable to tolerate off-loading or have poor prognosis diseases including malignant tumors
  • Serious chronic diseases such as liver, heart, kidney, or lung diseases
  • Presence of critical limb ischemia or osteomyelitis
  • Withdrawal of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

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

Lahore, Punjab Province, Pakistan, 54550

Actively Recruiting

Loading map...

Research Team

A

Azra Mehmood, PhD

CONTACT

A

Amna Arif, M.Phil.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here