Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
NCT ID: NCT05610865
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
28 participants
INTERVENTIONAL
2020-11-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control; Standard-of-care management
Saline dressing will be done as a routine care management.
Control; Standard-of-care management
Patients will undergo conventional wound care management.
Only PRP injection
Only PRP will be injected at the wound site.
Only PRP injection
Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.
PRP + SVF injection
SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.
PRP + SVF injection
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
Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.
PRP + ASCs injection
Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.
Interventions
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Control; Standard-of-care management
Patients will undergo conventional wound care management.
Only PRP injection
Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.
PRP + SVF injection
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
Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
60 Years
ALL
No
Sponsors
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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
University of the Punjab
OTHER
Responsible Party
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Azra Mehmood
Associate Professor
Principal Investigators
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Azra Mehmood, PhD
Role: PRINCIPAL_INVESTIGATOR
Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore
Sheikh Riazuddin, PhD
Role: STUDY_DIRECTOR
Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore
Locations
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Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CEMB-SC02
Identifier Type: -
Identifier Source: org_study_id