InnovaMatrix for Ulcers
(IDEAL Trial)
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Consecutive weekly application of PPECM for the 12-week study period, with no more than 12 applications
Follow-up
Participants are monitored for safety and effectiveness after treatment, including confirmation of wound closure
Treatment Details
Interventions
- InnovaMatrix® AC
Find a Clinic Near You
Who Is Running the Clinical Trial?
ConvaTec Inc.
Lead Sponsor