IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers

ConditionsWound HealUlcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConvaTec Inc.

About 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

Qualifiers

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.

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • InnovaMatrix® AC

Treatment groups

194 Participants
are divided into 2 treatment groups

Locations

9
California
Angel City Research90010, Los Angeles United States
Center for Clinical Research94115, San Francisco United States
ILD Research Center92081, Vista United States
Florida
Dinamo Research and Diagnostic Center33015, Hialeah United States

Sponsors and collaborators

ConvaTec Inc.

Lead sponsor