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Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

RecruitingPhase 1Ages 20 Years - 60 YearsAllUniversity of the Punjab
NCT05610865 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Control; Standard-of-care management
  • Only PRP injection
  • PRP + SVF injection
  • PRP + ASCs injection
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Where

1 site
Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
Lahore, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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