Clinical trial NCT03890172: Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Diabetic Foot Ulcers
Official title: Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot Ulcer
Keywords: platelets rich plasma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility 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

Primary outcomes:
measure: Change of ulcer size
timeFrame: 16 weeks
Secondary outcomes:
measure: time of wound healing
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Hanan Mohamoud
role: STUDY_DIRECTOR
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