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Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

NCT ID: NCT02134132

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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)

Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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platelet rich plasma

The patients with diabetic foot ulcer who receive PG treatment.

Group Type ACTIVE_COMPARATOR

Platelet Gel

Intervention Type BIOLOGICAL

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

Placebo

The patients with diabetic foot ulcer who receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Platelet Gel

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of regenerative medicine department &cell therapy center of Royan Institute

Behnam Molavi, MD

Role: STUDY_DIRECTOR

Department of vascular & Trauma Surgery of Sina Hospital

Seyedeh Esmat Hosseini, Bs

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine & cell therapy of Royan Institute

Alireza Goodarzi, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine of Royan Institute

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

Related Links

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http://Royaninstitute.org

Related Info

Other Identifiers

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Royan-PVD-003

Identifier Type: -

Identifier Source: org_study_id