A Phase 2 interventional study of debridement of the wound and platelet rich plasma in Platelet Rich Plasma, sponsored by Zagazig University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Zagazig University · Phase 2, Interventional, and Treatment
In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.
The term "chronic wound" was first used in literature in the 1950s to refer to wounds that were difficult to heal or did not follow a normal healing process. However, the term has met criticism for its uncertainty regarding the duration of chronicity. Martin \& Nunan, 2015, defined a "chronic wound" as a barrier defect that has not healed in 3 months, and Leaper \& Durani, 2008, defined it as a wound that lacks a 20-40% reduction in its size after 2-4 weeks of optimal treatment or when there is no complete healing after 6 weeks. Recent reviews have highlighted the lack of consensus regarding the definition of a "chronic wound" and the need for further researches in this area.
Diabetic foot ulcer is a major complication of diabetes mellitus and is the major component of diabetic foot syndrome. This medical condition affects 15% of all patients with diabetes mellitus. Alvarsson et al. in 2012 reported that up to 88% of all lower leg amputations were related to diabetic foot ulcers.
The impact of chronic wounds on the health and quality of patients' life and their families should not be underestimated. Patients with chronic wounds may experience chronic pain, loss of function and mobility, depression, and anxiety, increased social stress and isolation, prolonged hospitalization, increased financial burden, and increased morbidity and mortality.
Growth factors (GFs) play an essential role in the process of wound healing and tissue regeneration. Each GF has more than one effect on the healing process and acts by binding to specific cell membrane receptors on the target cells. Growth factors' effects include promoting chemotaxis, inducing cell migration and proliferation, and stimulate cells to upregulate protein production. These growth factors not only regulate cell migration and proliferation but also promote angiogenesis and remodel the extracellular matrix, creating an ideal environment that favors the cutaneous wound healing process.
Over the last decades, the use of emerging cellular therapies, such as platelet-rich plasma (PRP), has more attention in a variety of diseases and settings for its potential use in the regenerative medicine as a therapeutic agent and can have an adjunctive role in a standardized, quality treatment plan.
PRP is defined as plasma containing above-baseline concentrations of platelets, which is from 140 000-400 000/μl. PRP is isolated through the centrifugation of whole blood. Simply, its actions are based on the infusion of elevated platelets, thereby theoretically enhancing the biological healing capacity and tissue generation in the wound bed. Enzyme-linked immunosorbent assay studies of PRP have quantified the presence of increases in GFs such as transforming GF β, epidermal GF, and platelet-derived GF. Through degranulation of the alpha granules in platelets, PRP can secrete various GFs, which have been documented to initiate the wound healing process
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
chronic diabetic foot ulcer was treated by platelet rich plasma
Procedure: debridement of the wound · Biological: platelet rich plasma · Procedure: conventional dressing
chronic diabetic foot ulcer was treated by conventional dressing
Procedure: debridement of the wound · Procedure: conventional dressing
The edges and the floor of the wound were firstly debrided, and any callosities around the wound were removed. This was repeated if needed when callosities around the wound reappeared. By this technique, the chronic wound was transformed into an acute one
Part of activated PRP was injected around the wound and under the base of the wound, while another portion of PRP was left over the floor of the wound and let to coagulate and form a gel.
The wound was irrigated by normal saline, covered by vaseline gauze then sterile dressing. Repeated dressing every two days till 20 weeks, if the wound failed to heal at that time
size of the ulcer reduce to zero cm
complete coverage of the ulcer base by healthy tissue
Time frame: 20 weeks
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Zagazig University