NCT05610865RecruitingPhase 1
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds
Source: ClinicalTrials.gov · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 26 Oct 2022
- Start date
- 20 Nov 2020
- Primary completion date
- Dec 2025
- Lead sponsor
- University of the Punjab
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05610865
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 28
- From 20 Nov 2020 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Uncontrolled hyperglycemia (HbAlc \> 9%)
- Patients with critical limb ischemia and osteomylitis
- Withdrawal of informed consent
Who the study is looking for
- 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
Age in the registry: 20 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC) Coordinator of this site? Confirm its status | Lahore | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.