Diabetic Foot UlcerNCT06292026
Efficacy of ProgenaMatrix™ in the Management of DFUs
A study testing ProgenaMatrix Keratin graft in people with Diabetic Foot Ulcer, run by ProgenaCare Global, LLC at 1 site in United States.
Trial summary
This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- ProgenaMatrix Keratin graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to Sep 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands and agrees that the standard treatment protocol will include the application of ProgenaMatrix™ as the standard of care for this project.
- Have participated in the informed consent process and signed a data collection and treatment specific informed consent.
- Be able and willing to comply with the data collection procedures, data collection visits, dressings, and off-loading.
- Have type I or type II diabetes mellitus with an Investigator-confirmed glycosylated hemoglobin (HBA1c) of less than or equal to 11.5% within 3 months prior treatment.
- Have at least one DFU Ulcer that has been in existence for a minimum of 4 weeks but no more than 12 months and meets all the following criteria:
- Ulcer is partial or full thickness without capsule/tendon/bone exposure.
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- Ulcer is on the foot or ankle.
- Ulcer area is greater than 1 sq. cm. but less than 18 sq. cm. post debridement. (Ulcers larger than 18 sq. cm. can be included with the approval of the Medical Monitor.)
- If the subject has more than one ulcer the data collection ulcer will be at the discretion of the Investigator.
- There is minimum of 1 cm between the ulcer treated and any other ulcer on the same foot.
- Have adequate vascular perfusion of the affected limb as defined by one of the following in order of preference.
- Ankle-Brachial index of greater than .65 and less the 1.3
- Toe Pressure of greater than 40 mmHg
- TcPO2 of greater than 40 mmHg
- Patient had vascular re-perfusion more than 30 days prior to inclusion in the study.
Who cannot join
- The study ulcer has unexplored tunneling, undermining, or sinus tracts.
- The patient is unable to safely ambulate with appropriate off-loading device.
- The patient has a known sensitivity to the suggested dressings.
- The patient has or is suspected of having gangrene, wound infection, necrosis, redness, pain, purulent drainage or is being treated by antibiotic for the treatment of the above.
- The patient has confirmed osteomyelitis of the foot with the ulcer.
- The patient is on steroid therapy, immunosuppressive or autoimmune therapy, radiation therapy of the foot, thrombosis.
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- History of bone of metastatic disease of the affected limb, radiation therapy or chemotherapy within 12 months prior to treatment.
- Pregnancy
- The patient is affected by any disease other than diabetes that can impair wound healing in the opinion of the Investigator.
- The patient has unstable Charcot with bony prominence that will inhibit wound healing.
- Excessive lymphedema that will inhibit off-loading.
- Is unwilling to allow the use ProgenaMatrix™ as the standard of care for this data collection project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Data Collection and Prospective Treatment Study to Evaluate the Efficacy of ProgenaMatrix™ in the Management of Diabetic Foot Ulcers
This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.
Read the detailed description
This is a multicenter data collection and treatment study with weekly updates to include pre and post debridement measurements of wound area, photographs and additional comments of wound appearance, exudate, and patient compliance. ProgenaMatrix™ will be used as the dressing to maintain a moist wound environment post-debridement. ProgenaMatrix™ is US Food and Drug Administration (FDA) cleared for the treatment of diabetic foot ulcers. The standard of care for diabetic foot ulcers (DFU) is removal of non-viable tissue, control of infection, maintain a moist wound environment and off-load the ulcer site. All aspects of this research are within the standard of care practice for the treatment of diabetic foot ulcers.
The use of ProgenaMatrix™ instead of a traditional dressing to maintain a moist healing wound environment is the only research intervention. Data on any adverse events related to treatment with ProgenaMatrix™ will be collected for research purposes.
The data in this study will be collected from subjects with controlled eligibility. The rationale for this control is to provide a real-world data set on subjects that have had their controllable comorbidities attenuated. This is good clinical practice at advanced wound treatment centers. This data will be statistically evaluated to provide a true closure rate when using ProgenaMatrix™ in a subject where standard of care treatments and assessments are followed. As with any good data set the control of as many variables as possible should provide a more consistent closure rate. This type data is not achievable in an observational study.
As the investigators move into randomized controlled trials, the investigators will maintain these criteria as the investigators strive to develop a predictive healing model when all aspects of patient care are considered. This will include which advanced dressing would be best applied to the wound based on patient status using an Artificial Intelligence program under development.
The investigators will also be looking at historical data on wound closure rates for traditional dressing as well as other advanced dressings that has been collected with similar eligibility criteria. All data input into our model will be controlled by similar eligibility requirements. This data will also be used as historical control for this study.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- ProgenaMatrix Keratin graft, standard of care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgenaMatrix Keratin graftDevice
place ProgenaMatrix graft on the wound
standard of careOther
Also called adaptic
apply non adherent dressing
| Study group | Role | What they receive |
|---|---|---|
| Treatment with ProgenaMatrix | Experimental | application of ProgenaMatrix daily for 12 weeks Receives: Device: ProgenaMatrix Keratin graft; Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to wound closure
The endpoint of this data collection process is to study the timepoint for total wound closure following the protocol procedures in the use of ProgenaMatrix™.
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start14 Mar 2022
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Model description
- The objective of this data collection is to look at outcomes and time points for ProgenaMatrix™ in the treatment of diabetic foot ulcers. Additionally, use the collected data to develop predictive wound closure models. There is a 1-week lead in period after initial debridement. If the wound is rapidly moving to closure after initial debridement and standard moist dressings, the withdrawal of these patients will prevent corruption of the true closure rate of ProgenaMatrix™. The objective of the treatment with ProgenaMatrix™ is to evaluate the closure rate in patients not responding to traditional moist therapy.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaCare Global, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292026
- Sponsor's protocol ID
- DFU/1
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Data Collection and Prospective Treatment Study to Evaluate the Efficacy of ProgenaMatrix™ in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06292026
- Acronym / sponsor ID
- DFU/1
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ProgenaCare Global, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.
Detailed description
This is a multicenter data collection and treatment study with weekly updates to include pre and post debridement measurements of wound area, photographs and additional comments of wound appearance, exudate, and patient compliance. ProgenaMatrix™ will be used as the dressing to maintain a moist wound environment post-debridement. ProgenaMatrix™ is US Food and Drug Administration (FDA) cleared for the treatment of diabetic foot ulcers. The standard of care for diabetic foot ulcers (DFU) is removal of non-viable tissue, control of infection, maintain a moist wound environment and off-load the ulcer site. All aspects of this research are within the standard of care practice for the treatment of diabetic foot ulcers.
The use of ProgenaMatrix™ instead of a traditional dressing to maintain a moist healing wound environment is the only research intervention. Data on any adverse events related to treatment with ProgenaMatrix™ will be collected for research purposes.
The data in this study will be collected from subjects with controlled eligibility. The rationale for this control is to provide a real-world data set on subjects that have had their controllable comorbidities attenuated. This is good clinical practice at advanced wound treatment centers. This data will be statistically evaluated to provide a true closure rate when using ProgenaMatrix™ in a subject where standard of care treatments and assessments are followed. As with any good data set the control of as many variables as possible should provide a more consistent closure rate. This type data is not achievable in an observational study.
As the investigators move into randomized controlled trials, the investigators will maintain these criteria as the investigators strive to develop a predictive healing model when all aspects of patient care are considered. This will include which advanced dressing would be best applied to the wound based on patient status using an Artificial Intelligence program under development.
The investigators will also be looking at historical data on wound closure rates for traditional dressing as well as other advanced dressings that has been collected with similar eligibility criteria. All data input into our model will be controlled by similar eligibility requirements. This data will also be used as historical control for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The objective of this data collection is to look at outcomes and time points for ProgenaMatrix™ in the treatment of diabetic foot ulcers. Additionally, use the collected data to develop predictive wound closure models. There is a 1-week lead in period after initial debridement. If the wound is rapidly moving to closure after initial debridement and standard moist dressings, the withdrawal of these patients will prevent corruption of the true closure rate of ProgenaMatrix™. The objective of the treatment with ProgenaMatrix™ is to evaluate the closure rate in patients not responding to traditional moist therapy.
| Arm | Type | Receives |
|---|---|---|
| Treatment with ProgenaMatrix | Experimental | Device: ProgenaMatrix Keratin graft, Other: standard of careapplication of ProgenaMatrix daily for 12 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Understands and agrees that the standard treatment protocol will include the application of ProgenaMatrix™ as the standard of care for this project.
- Have participated in the informed consent process and signed a data collection and treatment specific informed consent.
- Be able and willing to comply with the data collection procedures, data collection visits, dressings, and off-loading.
- Have type I or type II diabetes mellitus with an Investigator-confirmed glycosylated hemoglobin (HBA1c) of less than or equal to 11.5% within 3 months prior treatment.
- Have at least one DFU Ulcer that has been in existence for a minimum of 4 weeks but no more than 12 months and meets all the following criteria:
Key exclusion criteria (12 listed)
- The study ulcer has unexplored tunneling, undermining, or sinus tracts.
- The patient is unable to safely ambulate with appropriate off-loading device.
- The patient has a known sensitivity to the suggested dressings.
- The patient has or is suspected of having gangrene, wound infection, necrosis, redness, pain, purulent drainage or is being treated by antibiotic for the treatment of the above.
- The patient has confirmed osteomyelitis of the foot with the ulcer.
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 |
|---|---|---|
| ProgenaMatrix Keratin graftplace ProgenaMatrix graft on the wound | Device | Treatment with ProgenaMatrix |
| standard of careAlso: adapticapply non adherent dressing | Other | Treatment with ProgenaMatrix |
Primary outcome
time to wound closure
Time frame: 12 weeks of treatment
The endpoint of this data collection process is to study the timepoint for total wound closure following the protocol procedures in the use of ProgenaMatrix™.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProgenaMatrix Keratin graft in people with Diabetic Foot Ulcer, run by ProgenaCare Global, LLC at 1 site in United States.
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 15 inclusion and 12 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
time to wound closure (time frame: 12 weeks of treatment). 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 4 Mar 2024.