Diabetic Foot
Conditions
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.
Interventions
OTHERUmbilical 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.
Sponsors
Biomedical Research Foundation, Academy of Athens
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size. | six months | 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. |
Countries
Greece
Outcome results
None listed