Diabetic Foot Ulcer Clinical Trial
Official title:
Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers
Verified date | March 2019 |
Source | Assiut University |
Contact | Hanaa Mohammed |
Phone | 01094608083 |
hanaaried[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2021 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - diabetic patients 18 to 80 years of age, with at least one cutaneous ulcer, which did not improve significantly after at least 4 week ulcer standard treatments - ankle brachial index value = 0.6 - platelet count = 100,000 /mm 3 - no history of various drug or dressing allergies Exclusion Criteria: - - ulcer is due to non diabetic etiology - patients blood vessels are non compressible for ankle brachial index (ABI )testing - the presence of an infected wound and/or osteomyelitis, and/or a completely necrotic ulcer - active oncological disease. systemic treatment medications like corticosteroids, immunosuppressive agents, as well as radiation or chemotherapy at the target sites within 3 weeks before this study. - Screening platelets count less than 100,000mm3 - Screening hemoglobin less than10.5mg/dl - End stages renal disease,haematological,collagen vascular disease and bleeding disorders |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6. Review. — View Citation
Andia E R-AJ, Martin I, Abate M. Current concepts and translational uses of platelet rich plasma biotechnology. Biotechnology 2015. https://doi.org/10.5772/59954 Google Scholar
Andia I, Abate M. Platelet-rich plasma: underlying biology and clinical correlates. Regen Med. 2013 Sep;8(5):645-58. doi: 10.2217/rme.13.59. Review. — View Citation
Anitua E, Aguirre JJ, Algorta J, Ayerdi E, Cabezas AI, Orive G, Andia I. Effectiveness of autologous preparation rich in growth factors for the treatment of chronic cutaneous ulcers. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):415-21. — View Citation
Apelqvist J, Bakker K, van Houtum WH, Schaper NC; International Working Group on the Diabetic Foot (IWGDF) Editorial Board. The development of global consensus guidelines on the management of the diabetic foot. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S116-8. doi: 10.1002/dmrr.832. — View Citation
Bernuzzi G, Tardito S, Bussolati O, Adorni D, Cantarelli S, Fagnoni F, Rossetti A, Azzarone M, Ficarelli E, Caleffi E, Gazzola G, Franchini M. Platelet gel in the treatment of cutaneous ulcers: the experience of the Immunohaematology and Transfusion Centre of Parma. Blood Transfus. 2010 Oct;8(4):237-47. doi: 10.2450/2009.0118-09. — View Citation
Carter MJ, Fylling CP, Parnell LK. Use of platelet rich plasma gel on wound healing: a systematic review and meta-analysis. Eplasty. 2011;11:e38. Epub 2011 Sep 15. — View Citation
Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569. Review. — View Citation
Kakudo N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32. N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32.
Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9. Review. — View Citation
Liao HT, Marra KG, Rubin JP. Application of platelet-rich plasma and platelet-rich fibrin in fat grafting: basic science and literature review. Tissue Eng Part B Rev. 2014 Aug;20(4):267-76. doi: 10.1089/ten.TEB.2013.0317. Epub 2013 Dec 18. Review. — View Citation
Mohammadi MH, Molavi B, Mohammadi S, Nikbakht M, Mohammadi AM, Mostafaei S, Norooznezhad AH, Ghorbani Abdegah A, Ghavamzadeh A. Evaluation of wound healing in diabetic foot ulcer using platelet-rich plasma gel: A single-arm clinical trial. Transfus Apher Sci. 2017 Apr;56(2):160-164. doi: 10.1016/j.transci.2016.10.020. Epub 2016 Nov 2. — View Citation
Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25. Review. — View Citation
San Sebastian KM, Lobato I, Hernández I, Burgos-Alonso N, Gomez-Fernandez MC, López JL, Rodríguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of ulcer size | ulcer size will be measured with ruler/probe for length, width and depth and estimated by calculating the ulcer size in centimeter (cm 2). | 16 weeks | |
Secondary | time of wound healing | Complete wound closure over period of 16 weeks | 16 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04497805 -
Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers
|
Phase 2 | |
Withdrawn |
NCT03675269 -
Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:
|
N/A | |
Completed |
NCT04624516 -
Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
|
N/A | |
Not yet recruiting |
NCT06439667 -
VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
|
||
Recruiting |
NCT05608187 -
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
Not yet recruiting |
NCT06437028 -
Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.
|
N/A | |
Not yet recruiting |
NCT06278935 -
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
|
N/A | |
Withdrawn |
NCT05024656 -
AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers
|
N/A | |
Terminated |
NCT02202668 -
Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
|
N/A | |
Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
Completed |
NCT01951768 -
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
|
Phase 4 | |
Completed |
NCT01657474 -
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
|
N/A | |
Active, not recruiting |
NCT00389636 -
TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
|
N/A | |
Completed |
NCT01181440 -
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
|
Phase 3 | |
Enrolling by invitation |
NCT05888259 -
Plantar Pressure Distribution in Diabetic Foot Ulcer
|
N/A | |
Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
Not yet recruiting |
NCT05877378 -
Efficacy of PICO Single-use System in Chronic Ulcers
|
N/A | |
Recruiting |
NCT06037369 -
The Short Message-based Customized Standardized
|
N/A | |
Completed |
NCT03312595 -
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
|
N/A | |
Recruiting |
NCT04564443 -
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
|
N/A |