Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers (NCT05610865) | Clinical Trial Compass
RecruitingPhase 1
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
Pakistan28 participantsStarted 2020-11-20
Plain-language 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.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interview and visual inspection of ulcers recovery rate