Using stem cells from fat to treat diabetic foot ulcers
Official title: Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds
Run by University of the Punjab · NCT05610865 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Enrollment | 28 (estimated) |
| Sponsor | University of the Punjab Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | November 20, 2020 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | December 31, 2024 |
| Trial ID | NCT05610865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with uncontrolled hyperglycemia, severe infections, or critical limb ischemia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Single-layer placental graft plus standard care for stubborn diabetic foot ulcers
This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.
-
Evaluating human placental membrane products for treating nonhealing diabetic foot and venous leg ulcers
This study is testing whether using human placental products along with regular care can help people with stubborn diabetic foot and leg ulcers heal better.
-
Wound matrix treatments for nonhealing diabetic foot ulcers
This trial will test whether adding special wound matrix products to standard care helps close hard-to-heal diabetic foot ulcers in adults with type 1 or 2 diabetes within 12 weeks.
-
Evaluating a new placental-based treatment for diabetic foot ulcers
This study is testing if a new placental treatment can help adults with hard-to-heal diabetic foot ulcers get better faster when used alongside regular care.
-
Using dehydrated human amnion membrane to treat nonhealing diabetic foot ulcers
This study is testing if adding dehydrated human amnion membrane to regular care can help people with stubborn diabetic foot ulcers heal better.
-
Evaluating ENERGI-F703 GEL for diabetic foot ulcers
This study is testing if a new gel can help heal diabetic foot ulcers that haven't improved for at least four weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.