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

Conditions

• Ulcer
• Wound Heal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• InnovaMatrix® AC — DEVICE
  SOC plus weekly application of the study device

Study Details

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.

Key Dates

First listed

Sep 27, 2024

Start date

Feb 12, 2025

Status verified

Aug 2026

Primary completion

May 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

235 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Standard of Care (SOC)
  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.
• Experimental: Standard of Care + 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.

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 ]

Central Contacts

• Andrew Thomas
  07767036374
  [email protected]

Locations (21)

Find similar trials in Fresno, CA

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