Clinical Research Program

Clinical Results & Research

Featured Case

Stage 4 Sacral Pressure Ulcer with Osteomyelitis

86-year-old male · Unstageable sacral wound · Peripheral necrosis · Osteomyelitis of sacral bone

Within 7 weeks of continuous RashEndZ™ therapy: wound area reduced >80%, necrosis resolved at 3 weeks, tissue regrowth on previously exposed bone, antibiotics discontinued as inflammatory markers normalized.

Direct dose-response relationship confirmed — healing slowed when O₂ concentrator went out-of-spec.
Before · Day 1
Stage 4 sacral pressure ulcer Day 1
After · Day 45
Stage 4 sacral pressure ulcer Day 45
Wound Volume
Day 0: 57.8cc, Day 8: 49.5cc, Day 15: 37.5cc, Day 23: 32.2cc, Day 29: 32.2cc, Day 36: 25.0cc, Day 44: 13.5cc.
Volume (cc) O₂ out-of-spec
C-Reactive Protein
Day 1: CRP 112, Day 29: CRP 24, Day 47: CRP 19.
CRP (mg/L)
FDA IRB Approved

Florida Hospital Phase 0/1 Pilot Safety Study

Florida Hospital Tampa Bay Division · Approved March 2016 (reapproved 2017, 2018) · 17 screened, 10 entered, 6 completed · Target: IAD and pressure ulcers

Established foundational safety profile for continuous topical oxygen therapy. Study closed upon achieving primary safety endpoint. Data enabled FDA registration under 21 CFR 878.4020.

Zero adverse events. Safety confirmed over time.
Case Series

Florida Nursing Home Case Series

8 patients · Ages 68–96 · Multiple wound types

Stage 2 pressure ulcers, maceration, excoriation, IAD, severe diaper rash, and fungal infections across elderly long-term care population.

All 8 wounds healed within 7 days. One acute IAD case healed overnight.