The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers

The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers:a Randomized Controlled Trial

Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance tissue healing. Human umbilical cord blood platelet lysate (UCB-PL) contains a supraphysiological concentration of growth factors. The aim of the study is to evaluate the efficacy of umbilical cord blood platelet lysate (UCB-PL) gel for the treatment of diabetic foot ulcer.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Other: Umbilical cord blood platelel lysate gel

Detailed Description

110 patients with diabetic foot ulcer will be randomized to receive UCB-PL gel or regular dressing with normal saline. The diabetic foot ulcers will be first debrided to remove any necrotic and infected tissues or hyperkeratotic skin. Afterward, the wound area will be cleaned thoroughly with normal saline. Ulcer length, width and surface will be measured before any study procedure. The UCB-PL gel in the treatment group and the dressing with normal saline in the control group will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area. This will be repeated every three days for one month. After the fist one month of treatment, the patients will be followed up for a period of 20 weeks post-treatment. Care and management efforts will be provided at each visit included cleansing and assessing of the wound, obtaining an interim wound history, including information regarding adverse events, concomitant medications and other aspects of care since the last visit. Ulcers will be photographed at two weeks, at four weeks, at two months, at four months and at six months.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Catherine Stavropoulos-Giokas
    • Athens, Attiki, Greece, 12462
      • Vaia Lambadiari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age>18 years old
• patients with diabetic foot ulcer, foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces)
• ulcer with area(length x width) measurement<30 cm2
• non-infected ulcers

Exclusion Criteria:

• pregnacy
• venous ulcers
• clinical signs and symptoms of infection
• exposure of bone, muscle, ligaments, or tendons and the presence of tunneling

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Umbilical cord blood platelel lysate group; A Umbilical cord blood platelel lysate gel will be applied in diabetic foot ulcer every three days for one month.	Other: Umbilical cord blood platelel lysate gel; For the treatment group, a gel from Umbilical cord blood platelel lysat will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area.
Placebo Comparator: Control group; The control group will receive the clinical standard of care; removable of any necrotic, hyperkeratotic and infected tissue, cleansing of the wound with normal saline and covering of the ulcer with dressing with normal saline and then with a few layers of sterile gauze, and non-compressible bandage.	Other: Umbilical cord blood platelel lysate gel; For the treatment group, a gel from Umbilical cord blood platelel lysat will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size.	Primary endpoint was to investigate the efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size over the six months follow-up by using the imito-measure application.	six months

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Collaborators: Biomedical Research Foundation, Academy of Athens
• Investigators: Principal Investigator: Vaia Lambadiari, Professor, General University Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 411/05-06-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No