(CS-011) Real-world analysis of the effect of adjunctive Vaporous Hyperoxia Therapy on the healing of chronic wounds

Dustin Kruse, DPM, MA, FACFAS – Primary Investigator; Charles Zellen, DPM; Marissa Carter, MA,PhD – Statician

Introduction:

Vaporous Hyperoxia Therapy (VHT^®),a patented FDA-510(k) cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC).  VHT^® administers a low-frequency, noncontact, nonthermal ultrasonic mist with topical oxygen therapy (TOT). A retrospective analysis of patients with chronic wounds evaluated the healing effect of­­ VHT^®.

Methods:

We reviewed data of patients with chronic wounds (≥4 weeks) treated with VHT^® at 10 clinics from February 6, 2020, through August 30, 2022. After debridement (as appropriate), the limb was placed in the treatment basin, and a 56-minute treatment of alternating cycles of ultrasonic mist and TOT was administered. Wounds were offloaded and dressed appropriately.  Twice-weekly treatments occurred until the wound was healed (complete epithelialization and granulation). The number of wounds healed at 16 weeks and the percentage area and volume reduction (PAR/PVR) for non-healed wounds at 16 weeks were analyzed. A Kaplan-Meier healing analysis determined time to heal.

Results:

Data from 116 patients were reviewed; 43 (37%) patients with 59 wounds were eligible and included. Most patients were male (n = 29, 67%) and aged 65-74 years (n = 22, 51%). The mean (standard deviation) comorbidity count per patient was 4.6 (2.6). The wounds were predominantly DFUs (n = 52; 88%); 67% (n = 35) of these were Wagner 2 ulcers. The median (interquartile range) wound duration was 2 months (3.4). The median baseline wound area was 1.5 cm² (3.5). The median number of treatments was 18 (20); the median treatment length was 60 days (74). At 16 weeks, 46 (78%) wounds healed. The median time to heal was 9.3 weeks (95% Confidence Interval: 8.2-10.4). The mean (median) PAR/PVR for non-healed wounds were 59% (100%), and 62% (100%), respectively.

Discussion:

This real-world analysis of patients with multi-morbidities demonstrates that VHT^® healed most chronic wounds within 14 weeks. The hyper-saturation and oxygenation of the wounded tissue stimulate angiogenesis, reduce bioburden, and consistently accelerate granulation tissue formation by as much as 70% by volume in the first 4 weeks of VHT^® treatment.  VHT^® is an ideal adjunct therapy for patients benefitting from cellular tissue products.