(CR-007) Multicenter, Randomized Evaluation of Transforming Powder Dressing Versus Standard of Care for Wagner Grade 1 and 2 Diabetic Foot Ulcers

Marcel de Souza Borges Quintana, PhD – Consultant; Susan Rolniak St. John, MSN, APRN-NP – Clinical consultant; Janathan Saxe, MD, MBA – Consultant; John St. John, PhD – Consultant; Carolyn Yanavich, PhD – Consultant

Introduction:

Nearly 18.6 million people worldwide develop a diabetic foot ulcer (DFU) annually1.

DFUs are a major diabetes complication, drive hospitalizations, precede lower-extremity

amputations, and increase mortality risk.1 Although DFU care standards are established,

practice varies due to inconsistent dressing use and limited comparative evidence for

advanced products. This Phase IV, multicenter, randomized clinical trial evaluated the

effectiveness, usability, and resource implications of transforming powder dressing (TPD)

compared with standard-of-care (SOC) dressings for treatment of chronic DFUs.

Methods:

Adults with Wagner grade 1–2 DFUs were randomized 1:1 to TPD or SOC at 11

U.S. sites with weekly follow-up for 12 weeks or until closure. The aim was to assess

whether TPD could reduce wound management burden without adversely impacting clinical

outcomes. The primary endpoint was complete re-epithelialization sustained for two

consecutive visits; secondary endpoints included wound area reduction (WAR), dressingchange

frequency, debridement needs, recurrence, and usability.

Results:

135 participants were enrolled (mean age 62 years; 87% male).

Baseline wound size was significantly larger in the TPD arm (~80% greater median wound

area vs. SOC). Despite this, wound closure rates by Week 12 were comparable between

groups. TPD achieved significantly greater weekly WAR (51% relative improvement; p =

0.002), reduced dressing changes by 67% (p < 0.001), and required 33% fewer

debridements (p = 0.01). Pain scores during dressing changes were 59% lower in the TPD

cohort (p = 0.02) patient satisfaction favored TPD, with >80% reporting superior ease,

comfort, and convenience.

Discussion:

The TPD cohort demonstrated accelerated WAR, markedly lower treatment

burden, and high user satisfaction, supporting its potential as an efficient, patient-centered

option for DFU management across diverse clinical environments.