Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

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.

Conditions

• Diabetic Foot Ulcers

Interventions

BIOLOGICAL

Platelet Gel

Application of platelet gel in patients suffering from diabetic foot ulcers.

OTHER

Placebo

The patients with Diabetic foot ulcer who receive placebo instead of PL Gel.

Sponsors & Collaborators

• Royan Institute

  lead OTHER_GOV

Principal Investigators

• Hamid Gourabi, PhD · Head of Royan Institute

• Nasser Aghdami, MD,PhD · Head of regenerative medicine department &cell therapy center of Royan Institute

• Behnam Molavi, MD · Department of vascular & Trauma Surgery of Sina Hospital

• Seyedeh Esmat Hosseini, Bs · Department of Regenerative Medicine & cell therapy of Royan Institute

• Alireza Goodarzi, MSc · Department of Regenerative Medicine of Royan Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-03-31

Completion

2014-04-30

Countries

• Iran

Study Locations