Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT02134132|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : December 4, 2015
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|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
The patients with Diabetic foot ulcer who receive placebo instead of PL Gel.
- pain [ Time Frame: 3 months ]Evaluation the pain reduction by VAS measurement in patients with peripheral artery Disease.
- ABI [ Time Frame: 3 months ]Evaluation the Ankle Brakial Index (ABI) in patients 3 months after PG utilization.
- Quality of life [ Time Frame: 3months ]Evaluation the quality of life by SF36 measurement in patients with PAD.
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 ClinicalTrials.gov identifier (NCT number): NCT02134132
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|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|