The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.
Grade II and III (According to Wagner's classification system of Ulcer severity) are considered to be of the most common complications associated with Diabetes, which are mostly hard to heal using the conventional treatment methods which by consequence severely affects the quality and lifestyle of the diabetes patient. It's thought that the application of Autologous activated platelets "Resticutis" which secretes huge amounts of growth factors is capable of giving better results of which are: the stimulation of the healing process that includes contraction, granulation, tissue formation and epithelialization of the diabetic foot ulcer. Resticutis is obtained from an autologous 20 mL peripheral blood withdrawn in tubes containing 3.8% Sodium Citrate. Blood is then centrifuged to obtain Platelet-Rich Plasma -PRP- as per established method. PRP is then activated in a closed system by physical methods to obtain a final product of 5 mL of Resticutis which is injected intra-lesionally at ulcer margins per each session of therapy. It's hypothesized that a total of six injections throughout the period of the treatment are enough to achieve full closure of the DFU. The injections are given on days: 0,14,28,42,56, and 70 of the treatment period. The consenting patients will be randomized into 2 groups: One group will be given Resticutis, and the second one Platelet-Poor Plasma PPP as placebo. If patients in PPP group didn't achieve full healing after four-six injections, they're given a two weeks rest after which they are given Resticutis instead. This is mainly a phase 1 safety study, which means no formal statistical analysis will be applied to any of the data. Safety assessment will depend on the association of any adverse events during the course of the study, and efficacy as a secondary objective will be assessed by observing the healing time of DFUs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Autologous, Activated-Platelets type of Preparation
A preparation of low platelet plasma obtained by a high-speed centrifugation step.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.
Time frame: 2 months
Assess the efficacy of autologous Resticutis injection by clinical examination
To determine short term speed and effectiveness of autologous Resticutis as a platelet lysate derivative on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the healing time.
Time frame: 4 months
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