Health Trials

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

ConditionsDiabetic Foot UlcerDiabetes MellitusDiabetic FootDiabetic Foot InfectionDiabetic Foot Ulcer NeuropathicFoot Ulcer Due to Type 1 Diabetes MellitusFoot Ulcer Due to Type 2 Diabetes MellitusFoot UlcerDiabetes ComplicationsChronic Diabetic Ulcer of Left FootChronic Diabetic Foot Ulcer of Right Foot
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-60
SponsorUniversity of the Punjab

About this trial

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

Qualifiers

Type 1 or Type 2 Diabetes Mellitus

Age 20-60 years (Male/Female)

Body mass index 20-30 kg/m2

Suitable for liposuction

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

28 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of the Punjab

Lead sponsor

Centre of Excellence in Molecular Biology, University of the Punjab, Lahore

Collaborator

Higher Education Commission (Pakistan)

Collaborator

Jinnah Burn and Reconstructive Surgery Centre, Lahore

Collaborator

Source ClinicalTrials.gov