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Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT03890172
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hanaa Mohammed Riad, Assiut University

Brief Summary:
using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer Other: 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly Other: standard treatment

Detailed Description:

Diabetic foot ulcers (DFU) are one of the most frequent and difficult complications in diabetes. The risk for a diabetic patient to develop an ulcer during his life is estimated as being 25%. Ulcers are a frequent cause of lower limbs amputation and 84% of lower limb amputations are preceded by ulcers .

Diabetic ulcer (DU) is not only a serious clinical problem with negative impacts on both the life quality and survival time, but also an economic burden with significant contribution to high cost and lengthy hospitalizations. Furthermore, the non healing diabetic cutaneous ulcers along with the subsequent amputations may bring about costly to treat and painful disabilities. However, healing of the DU may be improved and most of the amputations may be prevented by more effective treatments based on diabetic education .

In spite of the high prevalence and morbidity associated with DFUs, current treatment options are limited. Current standard management consists of surgical debridement followed by frequent dressing changes with tight infection and glycemic control. Despite this comprehensive approach, complication and amputation rates remain high.

The use of platelet-rich plasma (PRP) has emerged as an adjunctive method for treating DFUs.

Platelet-rich plasma (PRP) preparations were first described in the 1980s as plasma with a platelet count above that found normally in peripheral blood.

First used in the field of hematology, PRP use has expanded throughout the fields of dermatology, oral-maxillofacial surgery, plastic surgery, cardiac surgery, ophthalmology, urology, and gynecology .

The concentration of platelets in PRP is 2-6 folds higher than that of whole blood .

The curative properties of PRP rely on the fact that platelets are a physiological reservoir of a variety of growth factors, with healing function which have an active role in tissue regeneration .

Platelets contain proteins, known as growth factors that trigger biological effects including directed cell migration (i.e. chemotaxis), angiogenesis, cell proliferation and differentiation, which are key elements in the process of tissue repair and regeneration.

Specifically, the platelet alpha-granules contain several of these molecules, including: platelet derived growth factor (PDGF),transforming growth factor B ( TGF-β), vascular endothelial growth factor (VEGF), epithelial growth factor (EGF), fibrinogen, fibronectin, and vitronectin.

In addition, platelet delta granules contain serotonin, histamine, dopamine, calcium, and adenosine, which act in tandem with the aforementioned growth factors to regulate wound healing .

platelets exert antimicrobial activity against some bacteria of the skin, and clinical data shows that the presence of infection is reduced in PRP-treated wounds.

The advantages and merits of PRP are apparent since it is easy, cost-effective and much more lasting compared to other standard treatments and being autologous in nature, it is free from communicable pathogens, making it a safe treatment modality with good clinical results


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study group
in this group the investigators will be managing diabetic wounds with platelet rich plasma treatment.
Other: 20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly
topical application of platelets rich plasma after Centrifugation at diabetic foot ulcer to study group ,history taking . Ankle brachial index (ABI) measuring and laboratory testes including hemoglobin A1c ( HgA1)c,cbc and prothrombin time( pt) and prothrombin concentration ( pc)

control group
In this group patients will receive the standard treatment in form of debridement and dressing twice weekly
Other: standard treatment
Subjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices.




Primary Outcome Measures :
  1. Change of ulcer size [ Time Frame: 16 weeks ]
    ulcer size will be measured with ruler/probe for length, width and depth and estimated by calculating the ulcer size in centimeter (cm 2).


Secondary Outcome Measures :
  1. time of wound healing [ Time Frame: 16 weeks ]
    Complete wound closure over period of 16 weeks



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
, The study included 60 patients of both sex from 18 to 80 years, with clean chronic diabetic foot ulcers divided into 2 equal groups. The study group in which PRP was used, and the control group receiving standard therapy The formed PRP was applied to the wound twice weekly.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890172


Contacts
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Contact: Hanaa Mohammed 01094608083 hanaaried@gmail.com
Contact: Essam Abdelmohsen 01001971906 dressam@gmail.com

Locations
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Egypt
Assiut University Not yet recruiting
Assiut, Egypt, 71511
Contact: essam abdelmohsen         
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Hanan Mohamoud Assiut University

Publications:
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
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.

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Responsible Party: Hanaa Mohammed Riad, assistant lecture, Assiut University
ClinicalTrials.gov Identifier: NCT03890172     History of Changes
Other Study ID Numbers: Platelets rich plasma
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanaa Mohammed Riad, Assiut University:
platelets rich plasma

Additional relevant MeSH terms:
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Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases