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Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02134132
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 4, 2015
Information provided by (Responsible Party):
Royan Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Biological: Platelet Gel Other: Placebo Phase 1 Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Utilization of Umbilical Cord Blood-derived Platelet Gel for Treatment of Diabetic Foot Ulcers,a Randomized Double Blind Clinical Trial
Study Start Date : January 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. pain [ Time Frame: 3 months ]
    Evaluation the pain reduction by VAS measurement in patients with peripheral artery Disease.

  2. ABI [ Time Frame: 3 months ]
    Evaluation the Ankle Brakial Index (ABI) in patients 3 months after PG utilization.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3months ]
    Evaluation the quality of life by SF36 measurement in patients with PAD.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02134132

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of regenerative medicine department &cell therapy center of Royan Institute
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
Additional Information:
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Responsible Party: Royan Institute Identifier: NCT02134132    
Other Study ID Numbers: Royan-PVD-003
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: November 2011
Keywords provided by Royan Institute:
Platelet gel
diabetic foot ulcer
umbilical cord blood
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases