Using stem cells from fat to treat diabetic foot ulcers
Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds
PHASE1 · University of the Punjab · NCT05610865
This study is testing if using stem cells from fat, along with a special blood product, can help heal chronic foot ulcers in people with diabetes.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | University of the Punjab (other) |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT05610865 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of uncultured adipose-derived stromal vascular fraction (SVF) and cultured adipose-derived stem cells (ASCs), both combined with platelet-rich plasma (PRP), in treating chronic diabetic foot ulcers. The approach involves harvesting autologous fat from patients, isolating the stem cells, and assessing their quality before injecting them into the wound area. The study aims to enhance healing by utilizing the regenerative properties of these cells and the growth factors present in PRP, ensuring safety through the use of the patient's own tissues.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20-60 with Type 1 or Type 2 diabetes and chronic foot ulcers of Wagner's grade I.
Not a fit: Patients with uncontrolled hyperglycemia, severe infections, or critical limb ischemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients suffering from chronic diabetic foot ulcers.
How similar studies have performed: While the use of stem cells for wound healing is a growing field, this specific combination of SVF, ASCs, and PRP in diabetic foot ulcers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lahore, Punjab Province
- Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC) — Lahore, Punjab Province, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Azra Mehmood, PhD — Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore
- Study coordinator: Azra Mehmood, PhD
- Email: azra_mehmood@hotmail.com
- Phone: +92-333-4107008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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