Ulcer HealingNCT05797285
Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers
A study testing human keratin graft in people with Ulcer Healing and Diabetic Foot Ulcer, run by ProgenaCare Global, LLC at 3 sites in United States.
Trial summary
The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer Healing, Diabetic Foot Ulcer
- What is being tested?
- human keratin graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Feb 2023to 20 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 or 2 diabetes mellitus
- Target diabetic foot ulcer with a minimum surface area of 1.0 cm^2 and a maximum surface area of 20.0 cm^2 measured post-debridement with photographic planimetry.
- Target ulcer must have been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care prior to initial screening
- Target ulcer must be located on the foot with at least 50% of its area below the malleolus
- Target ulcer must be full thickness on the foot or ankle that does not probe to bone
- Adequate circulation in the affected foot documented within 3 months of initial screening visit, as determined by one of the following: transcutaneous oximetry measurement (TCOM) greater or equal to 30 mmHg, ankle-brachial index (ABI) between 0.7 and 1.3, biphasic pulse volume recording (PVR), toe-brachial index (TBI) greater than 0.6, or arterial Doppler ultrasound evaluating for biphasic dorsalis pedis and posterior tibial vessels at the ankle level
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- If subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer
- Target ulcers on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization
- Subject must consent to using the prescribed off-loading method for the duration of the study
- Subject must agree to attend weekly study visits required by the protocol
- Subject must be willing and able to participate in the informed consent process
Who cannot join
- Subjects known to have a life expectancy of < 6 months
- Infection of the target ulcer or cellulitis in the surrounding skin
- Presence of osteomyelitis or exposed bone, or wounds that probe to bone or joint capsule on investigator's exam or radiographic evidence
- Infection in the target ulcer requiring systemic antibiotic therapy
- Subjects receiving immunosuppressants (including systemic corticosteroids > 10 mg Prednisone per day or equivalent) or cytotoxic chemotherapy
- Topical application of steroids to the ulcer surface within one month of initial screening
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- Subjects with previous partial amputation on the affected foot that impedes proper offloading of the target ulcer
- Subjects with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit
- Subjects with a serum creatinine level ≥ 3.0mg/dL within 6 months of randomization
- Surface area of the target ulcer reduces in size by more than 30% in the two weeks between the initial screening and randomization during which they are subject to standard of care
- Subjects with acute or inactive Charcot foot that impedes proper offloading of the target ulcer
- Women who are pregnant or considering becoming pregnant within the next 6 months
- Subjects with end stage renal disease requiring dialysis
- Subjects who participated in a clinical trial involving treatment with an investigational product within the previous 30 days
- Subjects who, in the opinion of the investigator, have a medical or psychological condition that may interfere with study assessments
- Subjects treated with hyperbaric oxygen therapy or a cellular and/or tissue product (CTP) in the 30 days prior to the initial screening visit
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Foot and Ankle Specialists of the Mid-Atlantic (FASMA)
Frederick, Maryland, 21703
Doctors Research Network
Miami, Florida, 33143
Foot and Ankle Specialists of the Mid-Atlantic (FASMA)
Salem, Virginia, 24153
About this study
Official title: A Randomized Clinical Pilot Evaluating The Efficacy For Two Application Regimens Of A Unique Keratin Based Graft In The Treatment Of Non-Healing Diabetic Foot Ulcers
The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs.
The primary questions to be answered are:
- How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And
- What is the change in wound area during the trial in each group?
Read the detailed description
ProgenaMatrix® is a human keratin graft that is 510K approved for application on diabetic foot wounds and has been shown in case studies and clinical practice to assist in wound healing . Additionally, a study published by Tang and Kirsner showed that keratin stimulates human keratinocyte migration and types IV and VII collagen expression. Therefore, based on this early promising data, a larger pilot is necessary to further validate these results and identify the likelihood of wound healing with weekly versus bi-weekly application. For consistency, one type of wound will be studied in this trial and DFU's have been chosen as they are some of the most common wounds seen in the wound clinics.
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared synthetic, absorbable skin substitute matrix. The commercially available product is ProgenaMatrix® Advanced Wound Graft and consists of Human Keratin Matrix. In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will be randomized to a 510K FDA cleared ProgenaMatrix® applied weekly and the other half will be randomized to a 510K FDA cleared ProgenaMatrix® applied bi-weekly (i.e., once every two weeks).
- Conditions
- Ulcer Healing, Diabetic Foot Ulcer
- Being tested
- human keratin graft
- Keywords
- Diabetic Foot Ulcer, Wound 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.
human keratin graftDevice
Also called ProgenaMatrix
The intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies.
| Study group | Role | What they receive |
|---|---|---|
| Weekly Human Keratin Graft Application | Experimental | Patients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied weekly to the target wound. Receives: Device: human keratin graft |
| Bi-Weekly Human Keratin Graft Application | Experimental | Patients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied every other week to the target wound. Receives: Device: human keratin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
The proportion of subjects that achieve complete closure of the target wound with each treatment.
Measured: 12 weeks
Secondary outcomes (5)
Time to Wound Closure
The time required for target ulcers to achieve complete closure with each treatment.
Measured: From date of randomization until date of documented wound closure, assessed up to 12 weeks
Wound Area Change
The change in target wound area between treatment visits.
Measured: From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks
Change in Peripheral Neuropathy
Changes in peripheral neuropathy of the foot with the target ulcer between treatment visits, assessed by the standard 10-point Semmes-Weinstein monofilament exam.
Measured: From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks
Change in Wound Pain
Changes in pain in the target ulcer assessed by the numerical pain rating scale from 0 (no pain) to 10 (worst pain possible).
Measured: From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks
Change in Quality of Life
Changes in patient quality of life relating to their wound using the wound quality of life assessment with 17 questions answered on a scale of 0 ("not at all") to 4 ("very much").
Measured: From date of first screening until date of documented wound closure or study conclusion, whichever comes first, assessed up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start28 Feb 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer HealingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. The study has two phases: a 14-day screening phase to determine eligibility, and a 13-week treatment phase. Half of the patients will be randomized to a 510K FDA cleared ProgenaMatrix applied weekly and the other half will be randomized to a 510K FDA cleared ProgenaMatrix applied bi-weekly (i.e., once every two weeks). SOC includes offloading the DFU with controlled ankle movement (CAM) boots or total contact casting, appropriate sharp or surgical debridement, and wound care covering with ProgenaMatrix followed by a padded 3-layer dressing of 4x4 gauze, soft roll, and compressive wrap.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaCare Global, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, DPM,MD,PhD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797285
- Sponsor's protocol ID
- PRG-PM-DFU-01
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Pilot Evaluating The Efficacy For Two Application Regimens Of A Unique Keratin Based Graft In The Treatment Of Non-Healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05797285
- Acronym / sponsor ID
- PRG-PM-DFU-01
- Conditions
- Ulcer Healing, Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Wound Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ProgenaCare Global, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 4 Apr 2023 (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.
The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®. In this trial, two groups of patients with diabetic foot ulcers (DFUs) will be randomized to receive treatment with ProgenaMatrix applied either weekly or bi-weekly to the target wound. Researchers will compare how weekly or bi-weekly application of ProgenaMatrix affects the healing of DFUs.
The primary questions to be answered are:
- How many patients achieve wound closure in 12 weeks with ProgenaMatrix treatment? And
- What is the change in wound area during the trial in each group?
Detailed description
ProgenaMatrix® is a human keratin graft that is 510K approved for application on diabetic foot wounds and has been shown in case studies and clinical practice to assist in wound healing . Additionally, a study published by Tang and Kirsner showed that keratin stimulates human keratinocyte migration and types IV and VII collagen expression. Therefore, based on this early promising data, a larger pilot is necessary to further validate these results and identify the likelihood of wound healing with weekly versus bi-weekly application. For consistency, one type of wound will be studied in this trial and DFU's have been chosen as they are some of the most common wounds seen in the wound clinics.
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared synthetic, absorbable skin substitute matrix. The commercially available product is ProgenaMatrix® Advanced Wound Graft and consists of Human Keratin Matrix. In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will be randomized to a 510K FDA cleared ProgenaMatrix® applied weekly and the other half will be randomized to a 510K FDA cleared ProgenaMatrix® applied bi-weekly (i.e., once every two weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this trial, two groups of subjects with diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. The study has two phases: a 14-day screening phase to determine eligibility, and a 13-week treatment phase. Half of the patients will be randomized to a 510K FDA cleared ProgenaMatrix applied weekly and the other half will be randomized to a 510K FDA cleared ProgenaMatrix applied bi-weekly (i.e., once every two weeks). SOC includes offloading the DFU with controlled ankle movement (CAM) boots or total contact casting, appropriate sharp or surgical debridement, and wound care covering with ProgenaMatrix followed by a padded 3-layer dressing of 4x4 gauze, soft roll, and compressive wrap.
| Arm | Type | Receives |
|---|---|---|
| Weekly Human Keratin Graft Application | Experimental | Device: human keratin graftPatients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied weekly to the target wound. |
| Bi-Weekly Human Keratin Graft Application | Experimental | Device: human keratin graftPatients randomized into this arm will receive standard of care (offloading, debridement, and three-layer outer dressing) with the test material, the human keratin graft, reapplied every other week to the target wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of type 1 or 2 diabetes mellitus
- Target diabetic foot ulcer with a minimum surface area of 1.0 cm^2 and a maximum surface area of 20.0 cm^2 measured post-debridement with photographic planimetry.
- Target ulcer must have been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care prior to initial screening
- Target ulcer must be located on the foot with at least 50% of its area below the malleolus
- Target ulcer must be full thickness on the foot or ankle that does not probe to bone
Key exclusion criteria (16 listed)
- Subjects known to have a life expectancy of < 6 months
- Infection of the target ulcer or cellulitis in the surrounding skin
- Presence of osteomyelitis or exposed bone, or wounds that probe to bone or joint capsule on investigator's exam or radiographic evidence
- Infection in the target ulcer requiring systemic antibiotic therapy
- Subjects receiving immunosuppressants (including systemic corticosteroids > 10 mg Prednisone per day or equivalent) or cytotoxic chemotherapy
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 |
|---|---|---|
| human keratin graftAlso: ProgenaMatrixThe intervention to be applied is an advanced wound care matrix composed of human keratin to be applied at two different treatment frequencies. | Device | Bi-Weekly Human Keratin Graft Application, Weekly Human Keratin Graft Application |
Primary outcome
Wound Closure
Time frame: 12 weeks
The proportion of subjects that achieve complete closure of the target wound with each treatment.
5 secondary outcomes
Time to Wound Closure
Time frame: From date of randomization until date of documented wound closure, assessed up to 12 weeks
Wound Area Change
Time frame: From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks
Change in Peripheral Neuropathy
Time frame: From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks
Change in Wound Pain
Time frame: From date of randomization until date of documented wound closure or study conclusion, whichever comes first, assessed up to 12 weeks
Change in Quality of Life
Time frame: From date of first screening until date of documented wound closure or study conclusion, whichever comes first, assessed up to 15 weeks
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 23 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
David G Armstrong, DPM,MD,PhD study chair
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human keratin graft in people with Ulcer Healing and Diabetic Foot Ulcer, run by ProgenaCare Global, LLC at 3 sites 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 11 inclusion and 16 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Wound Closure (time frame: 12 weeks). 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 23 Feb 2024.