Wound HealIDEALNCT06616844
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
A study testing InnovaMatrix® AC in people with Wound Heal and Ulcer, run by ConvaTec Inc. at 21 sites in United States.
Trial summary
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Ulcer
- What is being tested?
- InnovaMatrix® AC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 21 sitesUnited States
- Study dates
- 12 Feb 2025to Sep 2027
- 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
- Subjects at least 21 years old. At least 50% of the enrolled population must be \> 65 years of age.
- Known history of type 1 or type 2 diabetes.
- The patient must have a target ulcer meeting the following characteristics:
- A diabetic ulcer that is either Wagner Grade 1 or Wagner Grade 2 . ii. Located on the anatomical foot; defined as a minimum of 50% of ulcer area extending distal to the medial malleolus.
- The target ulcer must have been present for a minimum of 4 weeks and no longer than 52 weeks.
- The target ulcer must display evidence of delayed wound healing, defined as less than 50% wound area reduction over the four weeks preceding randomization.
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- At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post-debridement.
- If two or more diabetic foot ulcers with the same Wagner Grade are present, the Index ulcer must additionally be:
- the ulcer with the largest wound area; ii. ≥ 2cm distant from any other ulcer on the affected limb, post-debridement; iii. the only ulcer to be evaluated by the study (one patient, one wound).
- Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days i. ABI ≥ 0.7 and ≤ 1.3; ii. TBI ≥ 0.6; iii. TCOM ≥ 40 mmHg; iv. PVR: biphasic.
- BMI ≤45
- Subject is willing to participate in all procedures and follow-up evaluations necessary to complete the study.
- Subject has signed informed consent.
Who cannot join
- The potential subject is known to have a life expectancy of \<6 months.
- Index Ulcers will be excluded if they meet any of the following criteria upon assessment:
- Index ulcer determined to be due to a condition other than diabetes ii. Active Charcot deformity OR major structural abnormalities of the foot iii. Known or suspected local skin malignancy to the index diabetic ulcer iv. Wound duration \>12 months without intermittent closure
- The target ulcer exhibits 2 or more of the following signs or symptoms consistent with clinical infection:
- erythema that extends ≥ 0.5cm from wound edge ii. local increased warmth iii. purulent exudate iv. local swelling or induration v. local tenderness or pain
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator\'s exam or radiographic evidence.
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- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent), radiation therapy, cytotoxic chemotherapy, or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the target ulcer, as measured by digital planimetry or manual linear measurements (e.g. with a ruler), decreases by more than 25% in the 2 weeks prior to the initial screening visit ("historical" run-in period).
- The surface area of the target ulcer, as measured by digital planimetry, decreases by more than 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
- The potential subject is unable to adhere to therapeutic offloading, if required by anatomical location of target ulce.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
- Potential subjects with a sensitivity or allergy to porcine materials or collagen will be excluded.
- Potential subjects with religious or personal objection to use of porcine- or animal-derived materials will be excluded.
- A subject with a disorder that would create unacceptable risk of treatment complications is excluded.
- Subjects will be considered ineligible for enrolment if any of the following criteria are met:
- Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- In the past 6 months, having undergone a revascularization procedure aimed at increasing blood flow in the target limb OR any amputation affecting the target limb
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Boston Medical Center
Boston, Massachusetts, 02118
First Excellence Research Group
Doral, Florida, 33178
White-Wilson Wound Care Center
Fort Walton Beach, Florida, 32547
Limb Preservation Platform
Fresno, California, 93710
US-FAS
Hagerstown, Maryland, 21742
Dinamo Research and Diagnostic Center
Hialeah, Florida, 33015
Innovative Medical Research of Texas
Houston, Texas, 77065
New Dawn Wellness and Medical Research Center
Houston, Texas, 77082
University of Florida Jacksonville
Jacksonville, Florida, 32209
Indiana Foot & Ankle
Jasper, Indiana, 47456
Angel City Research
Los Angeles, California, 90010
Clemente Clinical Research
Los Angeles, California, 90033
University of Pittsburgh Medical Center (UMPC)
McKeesport, Pennsylvania, 15132
Northwell Health Comprehensive Wound Healing Center
New Hyde Park, New York, 11042
Sunshine Ankle and Foot Experts
Orlando, Florida, 32828
US-FAS
Raleigh, North Carolina, 27609
Valiance Clinical Research
San Diego, California, 92117
Center for Clinical Research
San Francisco, California, 94115
Lenus Research and Medical Group, LLC
Sweetwater, Florida, 33172
Valiance Clinical Research
Tarzana, California, 91356
ILD Research Center
Vista, California, 92081
About this study
Official title: Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Conditions
- Wound Heal, Ulcer
- Being tested
- InnovaMatrix® AC
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnovaMatrix® ACDevice
Also called Porcine Placental ExtraCellular Matrix (PPECM)
SOC plus weekly application of the study device
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited; Wound bed debridement, if clinically indicated. Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate; A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin; Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and, Appropriate use of systemic antibiotics. |
| Standard of Care + Intervention | Experimental | SOC arm with the following modifications:
* Consecutive weekly application of PPECM for the 12-week study period.
* Subjects will receive no more than 12 applications of PPECM
Note: PPECM should be applied after standard wound cleansing and debridement procedures, prior to the application of primary wound dressing, in accordance with the IFU. Receives: Device: InnovaMatrix® AC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if PPECM augmented care is superior to SOC in the closure of diabetic foot ulcers at 12 weeks.
Measure the incidence of complete wound closure, defined as 100% reepithelialization of the wound without drainage, confirmed at a second clinical visit occurring at least 2-weeks after the visit where wound closure was initially observed
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 posted27 Sep 2024
- Study start12 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616844
- Sponsor's protocol ID
- WC-24-453
- Acronym
- IDEAL
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: A Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06616844
- Acronym / sponsor ID
- IDEAL / WC-24-453
- Conditions
- Wound Heal, Ulcer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Sep 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.
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited; Wound bed debridement, if clinically indicated. Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate; A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin; Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and, Appropriate use of systemic antibiotics. |
| Standard of Care + Intervention | Experimental | Device: InnovaMatrix® ACSOC arm with the following modifications: * Consecutive weekly application of PPECM for the 12-week study period. * Subjects will receive no more than 12 applications of PPECM Note: PPECM should be applied after standard wound cleansing and debridement procedures, prior to the application of primary wound dressing, in accordance with the IFU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects at least 21 years old. At least 50% of the enrolled population must be \> 65 years of age.
- Known history of type 1 or type 2 diabetes.
- The patient must have a target ulcer meeting the following characteristics:
- If two or more diabetic foot ulcers with the same Wagner Grade are present, the Index ulcer must additionally be:
- Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days i. ABI ≥ 0.7 and ≤ 1.3; ii. TBI ≥ 0.6; iii. TCOM ≥ 40 mmHg; iv. PVR: biphasic.
Key exclusion criteria (24 listed)
- The potential subject is known to have a life expectancy of \<6 months.
- Index Ulcers will be excluded if they meet any of the following criteria upon assessment:
- The target ulcer exhibits 2 or more of the following signs or symptoms consistent with clinical infection:
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator\'s exam or radiographic evidence.
- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent), radiation therapy, cytotoxic chemotherapy, or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).
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® ACAlso: Porcine Placental ExtraCellular Matrix (PPECM)SOC plus weekly application of the study device | Device | Standard of Care + Intervention |
Primary outcome
To determine if PPECM augmented care is superior to SOC in the closure of diabetic foot ulcers at 12 weeks.
Time frame: 12 weeks
Measure the incidence of complete wound closure, defined as 100% reepithelialization of the wound without drainage, confirmed at a second clinical visit occurring at least 2-weeks after the visit where wound closure was initially observed
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 22 Oct 2026.
- 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.
21 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 in people with Wound Heal and Ulcer, run by ConvaTec Inc. at 21 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 24 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
To determine if PPECM augmented care is superior to SOC in the closure of diabetic foot ulcers at 12 weeks. (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 22 Oct 2026.