Diabetes Mellitus Clinical Trial
Official title:
Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC) | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
University of the Punjab | Centre of Excellence in Molecular Biology, University of the Punjab, Lahore, Higher Education Commission (Pakistan), Jinnah Burn and Reconstructive Surgery Centre, Lahore |
Pakistan,
Álvaro-Afonso FJ, Sanz-Corbalán I, Lázaro-Martínez 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. Review. — View Citation
Carstens MH, Quintana FJ, Calderwood ST, Sevilla JP, Ríos 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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. Epub 2016 May 24. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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