Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

NCT02134132 | Completed Phase 1 DMC

• 1 other identifier: Royan-PVD-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers

Keywords

Platelet gel; diabetic foot ulcer; umbilical cord blood

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Quality of life

  3months

Study Arms (2)

platelet rich plasma

ACTIVE COMPARATOR

The patients with diabetic foot ulcer who receive PG treatment.

Biological: Platelet Gel

Placebo

PLACEBO COMPARATOR

The patients with diabetic foot ulcer who receive placebo.

Other: Placebo

Interventions

Platelet Gel BIOLOGICAL

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

platelet rich plasma

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 4, 2015

Record last verified: 2011-11

Locations

IR (1)