Foot Ulcer, DiabeticProcentaNCT05099887
Use of Procenta® Conformable Barrier for Non-Healing Foot & Ankle Ulcers in Patients With Diabetes Mellitus Types I and II
A study testing Procenta conformable barrier in people with Foot Ulcer, Diabetic, run by The VA Western New York Healthcare System.
Trial summary
Procenta® has been successful in facilitating closure of non-healing diabetic ulcers in patients where proper wound care management/practice has failed along with other allo- and xenografts. Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Procenta conformable barrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Mar 2022
- Phase
- Interventional
- 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 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must have a non-healing ulcer associated with diabetes mellitus
- Ulcer must have a minimum surface area of 0.5cm2 and a maximum surface area of 10.0cm2 i. Wound depth is not a criterion, though it will be documented throughout the study
- Failed conventional wound care treatments
- Amputation candidate
Who cannot join
- Co-morbidities which do not allow the ulcer to be linked to diabetic pathology will be excluded from the study
- o This is intended to limit the number of probable causes/contributing factors related to the ulcer. Commonly associated conditions, such as peripheral vascular disease is not an exclusion criterion, though it is documented in form, Enrollment Application Form for VAWNY072020PRODFU (IRB692.F01)
- Wounds with active infections or gangrene
- Active carcinoma(s)
- Wounds where bone is necrosing, avascular necrosis
- Multiple ulcers on the same foot/ankle
About this study
Official title: Use of Procenta® Conformable Barrier in Recovery of Non-Healing Foot & Ankle Ulcers in Patients With Diabetes Mellitus Types I and II
Procenta® has been successful in facilitating closure of non-healing diabetic ulcers in patients where proper wound care management/practice has failed along with other allo- and xenografts. In each individual case study where diabetes mellitus was pathological, unique wound morphologies with high variability in all three dimensions showed significant progress or were fully closed after at least one application of Procenta®. In the present study, the investigators seek to investigate the efficacy of the product over a 90-day treatment time-course with a larger sample size of patients suffering from non-healing wounds due to diabetes mellitus types I or II (diabetes mellitus). As a result, the investigators hope to better understand the potential and limitations of the product under these conditions with the anticipation that a significant number of patients will recover, avoid amputation, and return to a normal daily life.
Read the detailed description
Study Design Overview:
Potential candidates are diabetes mellitus type I or II patients with ulcers on the foot and ankle with no-to-minimal associated co-morbidities, regardless of age. The investigators anticipate the patient pool is likely to be in the range of 60-95 years of age. For this study, patients must have failed previous treatments which are in accordance with proper wound management practices and are considered to be typical applications/regiments. Patient's eligible for the current study should be candidates for amputation and failed traditional wound care practices and treatment alternatives. Diabetic ulcers of the foot and ankle should have a minimum surface area of 0.5cm2 and a maximum of 10.0 cm2.
Patients meeting selection criteria should be consulted regarding the application of Procenta® as an alternative to other treatments and/to surgeries. Once properly advised, the patient enrollment will begin with the execution of the Research Informed Consent Document from the Department of Veterans Affairs and the document, Informed Consent for Use of Procenta® for VAWNY072020PRODFU (IRB693) for the study. When scheduled for Procenta® application, the physician will complete form, Initial Application Form for VAWNY072020PRODFU (IRB692.F02), where the condition of the ulcer and procedure data will be recorded.
Application of one unit of the tissue allograft Procenta® (Catalog # 001050, 200mg) per ≤2.5cm2 ulcer surface area will be the protocol standard. Up to 4 units may be applied to a wound within the range described at each office visit and should fill ≥70% of the wound volume. The study will enroll 10 patients, where Procenta® is applied up to once every 7 days over a 12-week time-course. Data will be collected in the form of physician reporting during the initial application and at each follow-up visit on forms, Initial Application Form for VAWNY072020PRODFU (IRB692.F02) and Week (1-12) Follow-Up Form for VAWNY072020PRODFU (IRB692.F03). The patient will also be required to report on their quality of life at each follow-up on the Quality of Life Questionnaire for VAWNY072020PRODFU (IRB692.F04) and Foot and Ankle Ability Measure (FAAM) at the time of enrollment and at the end of the study period. Patients must agree to a 90-day treatment period, as well as a standard 6-month follow-up.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Procenta conformable barrier
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procenta conformable barrierBiological
Wound care dressing biologic allograft
| Study group | Role | What they receive |
|---|---|---|
| wound application | Other | Application of Procenta as wound cover Receives: Biological: Procenta conformable barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Wound closure
Primary end points are percent of wound closure
Measured: through study completion, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The VA Western New York Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099887
- Sponsor's protocol ID
- 1591772
- Acronym
- Procenta
- Status last verified
- Oct 2021
- First submitted
- 17 May 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Procenta® Conformable Barrier in Recovery of Non-Healing Foot & Ankle Ulcers in Patients With Diabetes Mellitus Types I and II
- ClinicalTrials.gov ID
- NCT05099887
- Acronym / sponsor ID
- Procenta / 1591772
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The VA Western New York Healthcare SystemUS federal agency
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 29 Oct 2021 (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.
Procenta® has been successful in facilitating closure of non-healing diabetic ulcers in patients where proper wound care management/practice has failed along with other allo- and xenografts. In each individual case study where diabetes mellitus was pathological, unique wound morphologies with high variability in all three dimensions showed significant progress or were fully closed after at least one application of Procenta®. In the present study, the investigators seek to investigate the efficacy of the product over a 90-day treatment time-course with a larger sample size of patients suffering from non-healing wounds due to diabetes mellitus types I or II (diabetes mellitus). As a result, the investigators hope to better understand the potential and limitations of the product under these conditions with the anticipation that a significant number of patients will recover, avoid amputation, and return to a normal daily life.
Detailed description
Study Design Overview:
Potential candidates are diabetes mellitus type I or II patients with ulcers on the foot and ankle with no-to-minimal associated co-morbidities, regardless of age. The investigators anticipate the patient pool is likely to be in the range of 60-95 years of age. For this study, patients must have failed previous treatments which are in accordance with proper wound management practices and are considered to be typical applications/regiments. Patient's eligible for the current study should be candidates for amputation and failed traditional wound care practices and treatment alternatives. Diabetic ulcers of the foot and ankle should have a minimum surface area of 0.5cm2 and a maximum of 10.0 cm2.
Patients meeting selection criteria should be consulted regarding the application of Procenta® as an alternative to other treatments and/to surgeries. Once properly advised, the patient enrollment will begin with the execution of the Research Informed Consent Document from the Department of Veterans Affairs and the document, Informed Consent for Use of Procenta® for VAWNY072020PRODFU (IRB693) for the study. When scheduled for Procenta® application, the physician will complete form, Initial Application Form for VAWNY072020PRODFU (IRB692.F02), where the condition of the ulcer and procedure data will be recorded.
Application of one unit of the tissue allograft Procenta® (Catalog # 001050, 200mg) per ≤2.5cm2 ulcer surface area will be the protocol standard. Up to 4 units may be applied to a wound within the range described at each office visit and should fill ≥70% of the wound volume. The study will enroll 10 patients, where Procenta® is applied up to once every 7 days over a 12-week time-course. Data will be collected in the form of physician reporting during the initial application and at each follow-up visit on forms, Initial Application Form for VAWNY072020PRODFU (IRB692.F02) and Week (1-12) Follow-Up Form for VAWNY072020PRODFU (IRB692.F03). The patient will also be required to report on their quality of life at each follow-up on the Quality of Life Questionnaire for VAWNY072020PRODFU (IRB692.F04) and Foot and Ankle Ability Measure (FAAM) at the time of enrollment and at the end of the study period. Patients must agree to a 90-day treatment period, as well as a standard 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wound application | Other | Biological: Procenta conformable barrierApplication of Procenta as wound cover |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
- o This is intended to limit the number of probable causes/contributing factors related to the ulcer. Commonly associated conditions, such as peripheral vascular disease is not an exclusion criterion, though it is documented in form, Enrollment Application Form for VAWNY072020PRODFU (IRB692.F01)
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 |
|---|---|---|
| Procenta conformable barrierWound care dressing biologic allograft | Biological | wound application |
Primary outcome
Percent of Wound closure
Time frame: through study completion, approximately 6 months
Primary end points are percent of wound closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Procenta conformable barrier in people with Foot Ulcer, Diabetic, run by The VA Western New York Healthcare System.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Percent of Wound closure (time frame: through study completion, approximately 6 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 29 Oct 2021.