Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Control; Standard-of-care management

    Other intervention

    Patients will undergo conventional wound care management.

  • Only PRP injection

    Biological/Vaccine

    Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.

  • PRP + SVF injection

    Biological/Vaccine

    Uncultured cells (SVF) along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

  • PRP + ASCs injection

    Biological/Vaccine

    Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Treatment groups

28 Participants
are divided into 4 treatment groups
Group A: Control; Standard-of-care managementActive comparator 1 intervention
Group B: Only PRP injectionExperimental treatment 1 intervention
Group C: PRP + SVF injectionExperimental treatment 1 intervention
Group D: PRP + ASCs injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Interview and visual inspection of ulcers recovery rate

This will be done in terms of diameter (cm2) of wounds, monitored in both cell transplanted and standard care patients after week interval till 3 months.

Time frame
3 months

Secondary outcomes

1

Percentages (%) of wound closure rate (with respect to time) will be assessed.

Change in wound size (cm2) will be determined

Time frame
3 months

Other outcomes

Sponsors and contacts

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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
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