Diabetic FootPhase 4NCT05404295
The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers
A Phase 4 study testing Umbilical cord blood platelel lysate gel in people with Diabetic Foot, run by Attikon Hospital at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Umbilical cord blood platelel lysate gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesGreece
- Study dates
- 10 Jun 2019to 30 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnacy
- venous ulcers
- clinical signs and symptoms of infection
- exposure of bone, muscle, ligaments, or tendons and the presence of tunneling
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Catherine Stavropoulos-Giokas
Athens, Attica, 11527
Vaia Lambadiari
Athens, Attica, 12462
About this study
Official title: The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers:a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diabetic Foot
- Being tested
- Umbilical cord blood platelel lysate gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood platelel lysate gelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord blood platelel lysate group | Active comparator | A Umbilical cord blood platelel lysate gel will be applied in diabetic foot ulcer every three days for one month. Receives: Other: Umbilical cord blood platelel lysate gel |
| Control group | Placebo comparator | 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. Receives: Other: Umbilical cord blood platelel lysate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size.
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start10 Jun 2019
- Primary completion10 Jun 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Foundation, Academy of Athens
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
- Investigators
- Vaia Lambadiari, Professor, Principal investigator, General University Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404295
- Sponsor's protocol ID
- 411/05-06-2019
- Status last verified
- Dec 2023
- First submitted
- 31 May 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05404295
- Acronym / sponsor ID
- 411/05-06-2019
- Conditions
- Diabetic Foot
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- Biomedical Research Foundation, Academy of Athens
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord blood platelel lysate group | Active comparator | Other: Umbilical cord blood platelel lysate gelA Umbilical cord blood platelel lysate gel will be applied in diabetic foot ulcer every three days for one month. |
| Control group | Placebo comparator | Other: Umbilical cord blood platelel lysate gelThe 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- pregnacy
- venous ulcers
- clinical signs and symptoms of infection
- exposure of bone, muscle, ligaments, or tendons and the presence of tunneling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord blood platelel lysate gelFor 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. | Other | Control group, Umbilical cord blood platelel lysate group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
Related trials for Diabetic Foot
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaia Lambadiari, Professor principal investigator
General University Attikon Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Umbilical cord blood platelel lysate gel in people with Diabetic Foot, run by Attikon Hospital at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of UCB-PL in ulcer healing by assessing the change in ulcer size. (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.