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Tests treatment safety and results for Diabetic Foot Ulcer
Official title Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT05610865
What this study is testing
What is Only PRP injection?
Only PRP injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic foot ulcer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 60
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lahore, Punjab Province, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lahore, Punjab Province, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.