Clinical trial NCT05404295: The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers
Official title: The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: Biomedical Research Foundation, Academy of Athens
First posted: 2022-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Catherine Stavropoulos-Giokas
state: Attiki
city: Athens
country: Greece
facility: Vaia Lambadiari
state: Attiki
Study officials:
affiliation: General University Attikon Hospital
name: Vaia Lambadiari, Professor
role: PRINCIPAL_INVESTIGATOR
References: