Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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