Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

Utilization of Umbilical Cord Blood-derived Platelet Gel for Treatment of Diabetic Foot Ulcers,a Randomized Double Blind Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Biological: Platelet Gel; Other: Placebo

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)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• History of at least 4 weeks hospitalization
• Uncontrolled diabetes
• ejection fraction > 30%

Exclusion Criteria:

• mechanical origin for wound
• history of infectious, systemic diseases, Immune deficiency and coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: platelet rich plasma; The patients with diabetic foot ulcer who receive PG treatment.	Biological: Platelet Gel; Application of platelet gel in patients suffering from diabetic foot ulcers.
Placebo Comparator: Placebo; The patients with diabetic foot ulcer who receive placebo.	Other: Placebo; The patients with Diabetic foot ulcer who receive placebo instead of PL Gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	Evaluation the pain reduction by VAS measurement in patients with peripheral artery Disease.	3 months
ABI	Evaluation the Ankle Brakial Index (ABI) in patients 3 months after PG utilization.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Evaluation the quality of life by SF36 measurement in patients with PAD.	3months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Behnam Molavi, MD, Department of vascular & Trauma Surgery of Sina Hospital; Principal Investigator: Seyedeh Esmat Hosseini, Bs, Department of Regenerative Medicine & cell therapy of Royan Institute; Principal Investigator: Alireza Goodarzi, MSc, Department of Regenerative Medicine of Royan Institute

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: umbilical cord blood; diabetic foot ulcer; Platelet gel
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: Royan-PVD-003