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

Attikon University Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetic Foot

Treatments: Other: Umbilical cord blood platelel lysate gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05404295

411/05-06-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Umbilical cord blood platelel lysate group

Active Comparator group

Description:

A Umbilical cord blood platelel lysate gel will be applied in diabetic foot ulcer every three days for one month.

Treatment:

Other: Umbilical cord blood platelel lysate gel

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Umbilical cord blood platelel lysate gel