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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404295
• Other study ID #: 411/05-06-2019
• Status: Completed
• Phase: Phase 4
• Start date: June 10, 2019
• Est. completion date: March 30, 2023

Study information

• Verified date: December 2023
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 30, 2023
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

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.

Locations

Country	Name	City	State
Greece	Catherine Stavropoulos-Giokas	Athens	Attiki
Greece	Vaia Lambadiari	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Attikon Hospital	Biomedical Research Foundation, Academy of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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