Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134132
• Other study ID #: Royan-PVD-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 7, 2014
• Last updated: December 3, 2015
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: November 2011
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Evaluation the pain reduction by VAS measurement in patients with peripheral artery Disease.	3 months	Yes
Primary	ABI	Evaluation the Ankle Brakial Index (ABI) in patients 3 months after PG utilization.	3 months	Yes
Secondary	Quality of life	Evaluation the quality of life by SF36 measurement in patients with PAD.	3months	No

External Links

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