Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
Recruiting · NCT05610865 · Interventional (participants receive a specific treatment) · Lead sponsor: University of the Punjab
View the official record on ClinicalTrials.gov →Interventions studied
Control; Standard-of-care managementOnly PRP injectionPRP + ASCs injectionPRP + SVF injection
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.
Who can take part
Age range
20 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC) - Lahore, Punjab Province, Pakistan