← Back to all trials
Recruiting
NCT05610865
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
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
Sex: All
Ages: 20 Years – 60 Years
Phase: PHASE1
Enrollment: 28
Sponsor: University of the Punjab
Location: Pakistan
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.
Eligibility Criteria
Inclusion Criteria:Type 1 or Type 2 Diabetes MellitusAge 20-60 years (Male/Female)Body mass index 20-30 kg/m2Suitable for liposuctionCondition or Disease: Diabetic NeuropathyWound Type: Chronic foot ulcerApprox.
wound area: 2 cm2 - 8 cm2Wound Condition should be of Wagner's grade I (Limited to soft tissue)Duration of wound persistence: 6-24 WeeksTranscutaneous oxygen pressure > 30 mmHg, and an ankle brachial pressure index > 0.5.Already following an adequate off-loading methodProvided signed informed consentExclusion Criteria:Uncontrolled hyperglycemia (HbAlc > 9%)Presence of severe clinical sign of infectionInability to tolerate off-loading, and poor prognosis diseases including malignant tumors.Serious chronic disease i.e hepatic, heart, renal, pulmonary diseasesPatients with critical limb ischemia and osteomylitisWithdrawal of informed consent
Source: ClinicalTrials.gov (NCT05610865). StuddyBuddy aggregates publicly available trial information.