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

NCT ID: NCT05404295

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Umbilical cord blood platelel lysate gel

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Umbilical cord blood platelel lysate gel

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomedical Research Foundation, Academy of Athens

OTHER

Sponsor Role collaborator

Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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VAIA LAMBADIARI

Professor of Internal Medicine-Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vaia Lambadiari, Professor

Role: PRINCIPAL_INVESTIGATOR

General University Attikon Hospital

Locations

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Catherine Stavropoulos-Giokas

Athens, Attica, Greece

Site Status

Vaia Lambadiari

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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411/05-06-2019

Identifier Type: -

Identifier Source: org_study_id