Diabetic Foot UlcerNCT05687656
Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
A study testing InnovaMatrix AC porcine placental ECM therapy in people with Diabetic Foot Ulcer, run by ConvaTec Inc. at 5 sites in United States.
Trial summary
A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- InnovaMatrix AC porcine placental ECM therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of child bearing potential must satisfy the defined contraceptive criteria Exclusion criteria h.
- Patients who are willing and able to attend all follow up visits
- Subject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12% . Has a diabetic foot ulcer classified by the Wagner classification 1 or 2 and at least 0.75cm2 and less than 5.0 cm2 in surface area as determined by photographic planimetry at the time of enrollment.
- Index ulcer characteristics:
- Ulcer present for ≥ 30 days prior to (Day 0)
- Index ulcer is located below the ankle: at least 50% of the ulcer surface area is below the malleolus.
Show all 13Show fewer
- Subject has Body Mass Index (BMI) ≤ 45 at enrollment.
- Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or
- ABIs with results of ≥ 0.7 and ≤ 1.2, Or
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI >1.2 TBI (Toe Brachial Index) > 0.5.
- Patient able to ambulate at home or in the clinic with or without mobility aids
- 8. The subject is willing to accept treatment with a porcine based product 9. The subject is medically stable, in the opinion of the investigator
Who cannot join
- Index Ulcer Assessment:
- Penetrates down to muscle, tendon, or bone
- Presence of another diabetic foot ulcer within 2 cm of the index ulcer
- Index ulcer determined to be due to Active Charcot deformity or previous surgical correction for Charcot deformity.
- Wounds which occur in relation to major structural abnormalities of the foot, which would include amputations related to osteomyelitis or Charcot deformity
- Exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
Show all 26Show fewer
- Known or suspected local skin malignancy to the index diabetic ulcer
- Wound duration > one year without intermittent closure
- Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
- In the last 7 days - Hyperbaric oxygen (HBO) therapy
- In the last 10 days - Chemical debridement, hypochlorous acid or Dakin's solution, medical honey therapy
- In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
- In the last 30 days - study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem Wound Matrix )
- In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
- In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg
- Subject criteria that will make subject ineligible for enrollment:
- Known hypersensitivity to porcine based products
- Known osteomyelitis or active cellulitis requiring antimicrobial therapy at wound site
- End stage renal disease requiring dialysis.
- Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited
- Subjects currently receiving radiation therapy or chemotherapy
- Any pathology that would limit the blood supply and compromise healing or non-revascularizable surgical sites
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
SerenaGroup Austin Research Center
Austin, Texas, 78701
Serena Group Buffalo Research Center
Buffalo, New York, 14203
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
Three Rivers Hyperbaric and Wound Center
North Port, Florida, 34289
Atrium Medical Center
Stafford, Texas, 77477
About this study
Official title: A Prospective, Multi-center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
A Prospective, Non-Randomized, Multi-Center Observational Study
To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)
Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
Read the detailed description
This is a prospective, multi-center observational study . The trial will include 30 completed subjects at three (3) experienced clinical centers in the United States. The estimated enrollment period is 13 weeks. After completing a screening , the subjects will be enrolled and receive treatment followed for at least 12 weeks.
It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators' practices. No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects. Further, no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen.
All subjects will be used for the analysis of efficacy and safety data.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- InnovaMatrix AC porcine placental ECM therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnovaMatrix AC porcine placental ECM therapyDevice
All eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care moist wound therapy and offloading
| Study group | Role | What they receive |
|---|---|---|
| InnovaMatrix AC porcine placental ECM therapy | Experimental | Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading Receives: Device: InnovaMatrix AC porcine placental ECM therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing area using digital image
The primary endpoint for the study is assessment of ulcer area at Weeks 6 and 12 using the MolecuLight Imaging Device
Measured: 12 weeks
Secondary outcomes (3)
Wound Closure
Time to complete wound closure as defined by FDA
Measured: 12 weeks
Percentage area reduction
- Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction
Measured: 12 weeks
Adverse events
Adverse events as reported at weekly treatment visits
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start6 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Eligible subjects will be treated with a weekly application for 12 weeks of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687656
- Sponsor's protocol ID
- TLS-IM-001
- Status last verified
- May 2025
- First submitted
- 2 Dec 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05687656
- Acronym / sponsor ID
- TLS-IM-001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 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.
A Prospective, Non-Randomized, Multi-Center Observational Study
To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)
Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
Detailed description
This is a prospective, multi-center observational study . The trial will include 30 completed subjects at three (3) experienced clinical centers in the United States. The estimated enrollment period is 13 weeks. After completing a screening , the subjects will be enrolled and receive treatment followed for at least 12 weeks.
It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators' practices. No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects. Further, no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen.
All subjects will be used for the analysis of efficacy and safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible subjects will be treated with a weekly application for 12 weeks of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
| Arm | Type | Receives |
|---|---|---|
| InnovaMatrix AC porcine placental ECM therapy | Experimental | Device: InnovaMatrix AC porcine placental ECM therapyEligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of child bearing potential must satisfy the defined contraceptive criteria Exclusion criteria h.
- Patients who are willing and able to attend all follow up visits
- Subject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12% . Has a diabetic foot ulcer classified by the Wagner classification 1 or 2 and at least 0.75cm2 and less than 5.0 cm2 in surface area as determined by photographic planimetry at the time of enrollment.
- Index ulcer characteristics:
- Subject has Body Mass Index (BMI) ≤ 45 at enrollment.
Key exclusion criteria (26 listed)
- Index Ulcer Assessment:
- Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- Subject criteria that will make subject ineligible for enrollment:
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 |
|---|---|---|
| InnovaMatrix AC porcine placental ECM therapyAll eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care moist wound therapy and offloading | Device | InnovaMatrix AC porcine placental ECM therapy |
Primary outcome
Wound Healing area using digital image
Time frame: 12 weeks
The primary endpoint for the study is assessment of ulcer area at Weeks 6 and 12 using the MolecuLight Imaging Device
3 secondary outcomes
Wound Closure
Time frame: 12 weeks
Percentage area reduction
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
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.
Thomas E Serena, MD principal investigator
SerenaGroup, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnovaMatrix AC porcine placental ECM therapy in people with Diabetic Foot Ulcer, run by ConvaTec Inc. at 5 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 13 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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 Healing area using digital image (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 31 May 2025.