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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05404295
Recruitment Status : Recruiting
First Posted : June 3, 2022
Last Update Posted : June 27, 2022
Sponsor:
Collaborator:
Biomedical Research Foundation, Academy of Athens
Information provided by (Responsible Party):
VAIA LAMBADIARI, Attikon Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Other: Umbilical cord blood platelel lysate gel Phase 4

Detailed Description:
104 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers:a Randomized Controlled Trial
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 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.

Placebo Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05404295


Contacts
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Contact: Vaia Lambadiari, Professor 2105831148 vlambad@otenet.gr

Locations
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Greece
Catherine Stavropoulos-Giokas Recruiting
Athens, Attiki, Greece, 11527
Contact: Catherine Stavropoulos-Giokas    21 06597342    cstavrop@bioacademy.gr   
Vaia Lambadiari Recruiting
Athens, Attiki, Greece, 12462
Contact: Vaia Lambadiari, Professor    2105831148    vlambad@otenet.gr   
Sponsors and Collaborators
Attikon Hospital
Biomedical Research Foundation, Academy of Athens
Investigators
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Principal Investigator: Vaia Lambadiari, Professor General University Attikon Hospital
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Responsible Party: VAIA LAMBADIARI, Professor of Internal Medicine-Endocrinology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT05404295    
Other Study ID Numbers: 411/05-06-2019
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases