Clinical trial NCT02134132: Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers
Official title: Utilization of Umbilical Cord Blood-derived Platelet Gel for Treatment of Diabetic Foot Ulcers,a Randomized Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: Platelet gel
diabetic foot ulcer
umbilical cord blood
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2014-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: pain
timeFrame: 3 months
measure: ABI
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life
timeFrame: 3months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of regenerative medicine department &cell therapy center of Royan Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Department of vascular & Trauma Surgery of Sina Hospital
name: Behnam Molavi, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Medicine & cell therapy of Royan Institute
name: Seyedeh Esmat Hosseini, Bs
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Regenerative Medicine of Royan Institute
name: Alireza Goodarzi, MSc
role: PRINCIPAL_INVESTIGATOR
References: