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| Name | Class |
|---|---|
| Centre of Excellence in Molecular Biology, University of the Punjab, Lahore | UNKNOWN |
| Higher Education Commission (Pakistan) | OTHER |
| Jinnah Burn and Reconstructive Surgery Centre, Lahore | OTHER_GOV |
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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.
Under local or general anesthesia, autologous fat will be harvested by using a manual aspiration or syringe-assisted technique. SVF and ASCs isolation from autologous lipoaspirates will be done by enzymatic digestion method (collagenase Type-1 solution for 45 minutes at 37°C). Cell quality assessment will be done prior to transplantation by trypan blue exclusion assay and total populations and fractions of cells identified by immunocytochemistry / flow cytometry. PRP will be derived by centrifugation from 50-100ml blood collected in anticoagulant carrying bag, from patient at the day of transplantation. The injection volume will depend on the wound area of each patient. 2 million cells/ 0.5 ml PRP will be mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone & inside of wound surface bed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control; Standard-of-care management | Active Comparator | Saline dressing will be done as a routine care management. |
|
| Only PRP injection | Experimental | Only PRP will be injected at the wound site. |
|
| PRP + SVF injection | Experimental | SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells. |
|
| PRP + ASCs injection | Experimental | Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control; Standard-of-care management | Other | Patients will undergo conventional wound care management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages (%) of wound closure rate (with respect to time) will be assessed. | Change in wound size (cm2) will be determined | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azra Mehmood, PhD | Contact | +92-333-4107008 | azra_mehmood@hotmail.com | |
| Amna Arif, M.Phil. | Contact | +92-333-4161068 | amnaarif.qureshi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Azra Mehmood, PhD | Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore | Principal Investigator |
| Sheikh Riazuddin, PhD | Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC) | Recruiting | Lahore | Punjab Province | 54550 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33199085 | Background | Shao S, Pan R, Chen Y. Autologous Platelet-Rich Plasma for Diabetic Foot Ulcer. Trends Endocrinol Metab. 2020 Dec;31(12):885-890. doi: 10.1016/j.tem.2020.10.003. Epub 2020 Nov 13. | |
| 34169656 | Background | Nolan GS, Smith OJ, Heavey S, Jell G, Mosahebi A. Histological analysis of fat grafting with platelet-rich plasma for diabetic foot ulcers-A randomised controlled trial. Int Wound J. 2022 Feb;19(2):389-398. doi: 10.1111/iwj.13640. Epub 2021 Jun 24. |
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| Only PRP injection | Biological | Only PRP injected / cm2 intradermally at the border zone & inside of wound surface bed. |
|
| PRP + SVF injection | Biological | 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 | Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone & inside of wound surface bed. |
|
| 33826245 | Background | Carstens MH, Quintana FJ, Calderwood ST, Sevilla JP, Rios AB, Rivera CM, Calero DW, Zelaya ML, Garcia N, Bertram KA, Rigdon J, Dos-Anjos S, Correa D. Treatment of chronic diabetic foot ulcers with adipose-derived stromal vascular fraction cell injections: Safety and evidence of efficacy at 1 year. Stem Cells Transl Med. 2021 Aug;10(8):1138-1147. doi: 10.1002/sctm.20-0497. Epub 2021 Apr 7. |
| 27219884 | Background | Qin HL, Zhu XH, Zhang B, Zhou L, Wang WY. Clinical Evaluation of Human Umbilical Cord Mesenchymal Stem Cell Transplantation After Angioplasty for Diabetic Foot. Exp Clin Endocrinol Diabetes. 2016 Sep;124(8):497-503. doi: 10.1055/s-0042-103684. Epub 2016 May 24. |
| 20492632 | Background | Han SK, Kim HR, Kim WK. The treatment of diabetic foot ulcers with uncultured, processed lipoaspirate cells: a pilot study. Wound Repair Regen. 2010 Jul-Aug;18(4):342-8. doi: 10.1111/j.1524-475X.2010.00593.x. Epub 2010 May 11. |
| 29715071 | Background | Didangelos T, Koliakos G, Kouzi K, Arsos G, Kotzampassi K, Tziomalos K, Karamanos D, Hatzitolios AI. Accelerated healing of a diabetic foot ulcer using autologous stromal vascular fraction suspended in platelet-rich plasma. Regen Med. 2018 Apr;13(3):277-281. doi: 10.2217/rme-2017-0069. Epub 2018 May 1. |
| Background | Prakasam N, Prabakar MS, Reshma S, Loganathan K, Senguttuvan K. A clinical study of platelet rich plasma versus conventional dressing in management of diabetic foot ulcers. International Surgery Journal. 2018 Sep 25;5(10):3210-6. |
| 32723090 | Background | Alvaro-Afonso FJ, Sanz-Corbalan I, Lazaro-Martinez JL, Kakagia D, Papanas N. Adipose-Derived Mesenchymal Stem Cells in the Treatment of Diabetic Foot Ulcers: A Review of Preclinical and Clinical Studies. Angiology. 2020 Oct;71(9):853-863. doi: 10.1177/0003319720939467. Epub 2020 Jul 29. |
| 29256523 | Background | Khan A, Junaid N. Prevalence of diabetic foot syndrome amongst population with type 2 diabetes in Pakistan in primary care settings. J Pak Med Assoc. 2017 Dec;67(12):1818-1824. |
| 32131655 | Background | Yin S, Yang X, Bi H, Zhao Z. Combined Use of Autologous Stromal Vascular Fraction Cells and Platelet-Rich Plasma for Chronic Ulceration of the Diabetic Lower Limb Improves Wound Healing. Int J Low Extrem Wounds. 2021 Jun;20(2):135-142. doi: 10.1177/1534734620907978. Epub 2020 Mar 4. |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005534 | Foot Diseases |
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