194 Participants Needed

InnovaMatrix for Ulcers

(IDEAL Trial)

Recruiting at 8 trial locations
AT
Overseen ByAndrew Thomas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are taking immunosuppressants, high-dose corticosteroids, or medications that might interfere with wound healing, you may not be eligible to participate.

What data supports the effectiveness of the treatment InnovaMatrix® AC for ulcers?

Research on similar treatments, like the Integra Flowable Wound Matrix, shows promising results in healing diabetic foot ulcers, with a higher healing rate compared to standard wet dressings. This suggests that advanced wound matrices, like InnovaMatrix® AC, may also be effective in treating ulcers.12345

How does the treatment InnovaMatrix® AC differ from other treatments for ulcers?

InnovaMatrix® AC is unique because it is an acellular dermal matrix, which means it provides a scaffold for skin repair without containing any living cells. This type of treatment supports the body's natural healing process by promoting vascularization (formation of new blood vessels) and integration at the wound site, which can be particularly beneficial for hard-to-heal ulcers.12567

What is the purpose of this 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.

Eligibility Criteria

This trial is for individuals with hard-to-heal diabetic foot ulcers. Participants should be adults who can follow the study procedures and visit schedule. People are excluded if they have other significant health issues that could affect wound healing or if they're participating in another clinical study.

Inclusion Criteria

I am at least 21 years old.
Subjects must be willing to participate in all study procedures and follow-up evaluations
BMI must be ≤45
See 5 more

Exclusion Criteria

Subjects with a life expectancy of less than 6 months are excluded
My ulcers do not meet the specific exclusion criteria.
My target ulcers do not show signs of infection.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Consecutive weekly application of PPECM for the 12-week study period, with no more than 12 applications

12 weeks
Weekly visits for PPECM application

Follow-up

Participants are monitored for safety and effectiveness after treatment, including confirmation of wound closure

2 weeks
1-2 visits (in-person)

Treatment Details

Interventions

  • InnovaMatrix® AC
Trial Overview The trial is testing InnovaMatrix® AC, a new treatment for diabetic foot ulcers, against standard care alone. It's designed to see if adding InnovaMatrix® AC improves wound healing. Patients will be randomly assigned to either receive this new treatment along with standard care or just the standard care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + InterventionExperimental Treatment1 Intervention
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.
Group II: Standard of Care (SOC)Active Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

ConvaTec Inc.

Lead Sponsor

Trials
52
Recruited
5,900+

Findings from Research

In a study involving 130 adults with Stage III or IV pressure ulcers, the Oasis® Wound Matrix (SIS) treatment led to a 55% rate of 90% reduction in ulcer size, compared to 38% with standard care, indicating its effectiveness in promoting wound healing.
While the complete healing rate was 40% for the SIS group versus 29% for standard care, the difference was not statistically significant, suggesting that while SIS may enhance healing, it may not guarantee complete healing compared to standard treatments.
An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial.Brown-Etris, M., Milne, CT., Hodde, JP.[2019]
In a study of 60 patients with diabetic foot ulcers, the Integra Flowable Wound Matrix led to a significantly higher complete healing rate of 86.95% compared to 52.17% for the wet dressing, demonstrating its efficacy in treating these complex wounds.
The use of the Integra Flowable Wound Matrix was associated with lower rates of amputation and rehospitalization compared to the control group, highlighting its safety and effectiveness in managing diabetic foot ulcers.
To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial.Campitiello, F., Mancone, M., Della Corte, A., et al.[2022]
In a study of 299 participants with clinically infected diabetic foot ulcers, only 45.5% achieved healing within 12 months, highlighting the generally poor clinical outcomes for these patients.
Factors negatively impacting healing included longer ulcer duration (≥2 months) and higher PEDIS perfusion grades (≥2), while having a single ulcer was associated with better healing outcomes.
Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study.Ndosi, M., Wright-Hughes, A., Brown, S., et al.[2022]

References

An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. [2019]
To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial. [2022]
Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study. [2022]
Compounding Pearls -- Wound Care: Diabetic Foot Ulcers, Part 1. [2020]
A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control. [2021]
Products and technologies for treating patients with evidence-based pressure ulcers. [2022]
Differential Capability of Clinically Employed Dermal Regeneration Scaffolds to Support Vascularization for Tissue Bioengineering. [2021]
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