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

NCT05404295 | Completed Phase 4

• 1 other identifier: 411/05-06-2019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Umbilical cord blood platelel lysate group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Interventions

Umbilical cord blood platelel lysate gel OTHER

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.

Control group; Umbilical cord blood platelel lysate group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Attikon Hospital: lead
• Biomedical Research Foundation, Academy of Athens: collaborator

Study Sites (2)

Catherine Stavropoulos-Giokas

Athens, Attica, 11527, Greece

Location

Vaia Lambadiari

Athens, Attica, 12462, Greece

Location

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

• Vaia Lambadiari, Professor

  General University Attikon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine-Endocrinology

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: June 10, 2019
• Primary Completion: June 10, 2022
• Study Completion: March 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

GR (2)