Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Diabetes is a multiorgan disease and considered a major health problem in different
      societies. One of the complications the pain particularly in the extremities resulting from a
      process known as diabetic foot ulcer. The diabetic patients are subjected to many
      complications because of foot ulcers, many of them like as chronic wound disease or pressure
      ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to
      nursing care and take too long until pain relief. Among many tested materials and works for
      wound healing such as debridement, tissue oxygenation, and skin transplantation,
      platelet-derived compounds are allocated the pivotal position between investigators to tissue
      regeneration and shortening the wound healing process.

      Many of platelet components are procured from platelet rich plasma (PRP) from whole blood
      donation. Furthermore, it requires to an additional purification step to diminish the volume
      and facilitate handling in some studies. It means that platelet concentrates (PCs) may be
      obtained leading to more concentrated platelets in lower volume.

      Two types of granules in platelet is responsible for storage of many useful and different
      growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the
      ability to growth and differentiation of numerous cells. Also, the antibacterial effect of
      these growth factors has been reported.

      To better efficacy and comfortable utilization of platelet, it is feasible to form the
      platelet gel and then apply on wound sites.

      This study is a double blind randomized controlled trial to evaluate the positive effects of
      umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.
    

Detailed description: 
      In this study all qualified patients (based on the inclusion and exclusion criteria) were
      randomly allocated into three study groups by a Stratified Permuted Block randomization
      method: group A received platelet rich plasma gel, group B (placebo) received platelet poor
      plasma gel, and group C received lubricant gel.

      All of the patients underwent a standard long protocol for knee osteoarthritis. All patients
      with diabetic foot ulcer are selected.On average,in each instance, the amount of platelets in
      the peripheral bloodis4 to6 times the baseline level.

      Group A (interventional): application of 20-30mL of gel from platelet rich plasma (PRP) Group
      B (placebo): application of 20-30mL of gel from platelet poor plasma (PRP) Group C (control):
      application of 20-30 mL of lubricant gel (used typically for sonography)
    

Intervention name(s): Platelet Gel; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Application of platelet gel in patients suffering from diabetic foot ulcers.; The patients with Diabetic foot ulcer who receive placebo instead of PL Gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Platelet gel; diabetic foot ulcer; umbilical cord blood