NCT05610865 Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
| NCT ID | NCT05610865 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of the Punjab |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2020-11-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2020-11-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Azra Mehmood, PhD
PRINCIPAL INVESTIGATOR
Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore
Frequently Asked Questions
Who can join the NCT05610865 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05610865 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05610865 currently recruiting?
Yes, NCT05610865 is actively recruiting participants. Contact the research team at azra_mehmood@hotmail.com for enrollment information.
Where is the NCT05610865 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT05610865 clinical trial?
NCT05610865 is sponsored by University of the Punjab. The principal investigator is Azra Mehmood, PhD at Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore. The trial plans to enroll 28 participants.