013: Real-World Analysis of the Effect of Adjunctive Vaporous Hyperoxia Therapy on the Healing of Chronic Wounds   
Submission Category: Clinical Research   
Submitter: Chase Huskey – Vaporox 

Primary Author: David G. Armstrong, DPM

Introduction    
Vaporous hyperoxia therapy (VHT) is a FDA-510(k) cleared technology  used adjunctively with standard wound care. VHT administers a low-frequency, noncontact, nonthermal ultrasonic mist with concentrated oxygen therapy (COT). 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 affected limb was placed in the treatment basin, and a 56-minute treatment of alternating cycles of ultrasonic mist and COT was administered. Wounds were offloaded and dressed appropriately. Twice-weekly treatments occurred until the wound healed (complete epithelialization and granulation). The number of wounds healed at 16 weeks and the percentage area and volume reduction were analyzed. A Kaplan-Meier healing analysis determined time to heal. 

Results 

Data from 249 patients were reviewed; 40 (17%) patients with 53 wounds were eligible and included. Most patients were male (n = 26, 65%) and aged 65-74 years (n = 21, 53%). The mean [standard deviation (SD)] comorbidity count per patient was 4.6 (2.5). The wounds were predominantly DFUs (n = 47; 88%); 72% (n = 38) of these were Wagner 2 ulcers. Five patients were treated with VHT in combination with ≤5 cellular and/or tissue-based products (CTPs). The median (interquartile range) wound duration was 2.0 months (3.0). The median baseline wound area was 1.5 cm² (3.9). The median number of treatments was 18 (21); the median treatment length was 60 days (76.5). At 16 weeks, 41 (76%) wounds healed, including all 5 wounds treated with VHT and CTPs. The mean healing time was 14.5 weeks (95% Confidence Interval: 9.9-18.1). The respective mean percentage area and volume reduction over 16 weeks were 69% (156.7) and 82% (70.3). 

Discussion

This real-world analysis of patients with multimorbidities demonstrates that VHT healed most chronic wounds within 14 weeks. The hypersaturation and oxygenation of the wound tissue stimulate angiogenesis, reduce bioburden, and accelerate granulation tissue formation. VHT also appears to accelerate healing in wounds that are also treated with CTPs, but this finding warrants further investigation.

014: Diabetes-Related Extremity Amputation Depression & Distress (DREADD) 
Submission Category: Clinical ResearchSubmission Category: Clinical Research   
Submitter and Primary Author: Brandon Brooks, DPM, MPH 
Co-Author(s): Levi M. Brooks, Allison S. Arp, MS, Bradley M. Brooks, DO, Cyaandi R. Dove, DPM, Lee C. Rogers, DPM, Rosemay Michel, DPM, Valentina Clinton, BS, Jonathan Labovitz, DPM, David G. Armstrong, DPM, MD, PhD

Introduction  
Of the roughly thirty-eight million people with diagnosed Type 2 Diabetes Mellitus (T2DM) in the US, up to 34% will develop a diabetic foot ulcer at some point, up to 50% of those who develop an ulcer will experience recurrent ulcers, and approximately 18% of patients with a diabetic foot ulcer will undergo lower-limb amputation (LLA). Given that depression in the diabetic population is associated with non-compliance, poor diet, and increased “no-shows,” we aimed to determine if depressive symptoms change following a minor amputation. 

Methods  
Our outcome of interest was Patient Health Questionnaire-9 (PHQ-9) scores; the PHQ-9 is commonly used to screen for clinical depression. We conducted a mixed methods study consisting of semi-structed interviews (n=16; table 1) and a retrospective cohort (n=20) of patients with T2DM who underwent a non-traumatic, minor amputation of a single toe (partial or total). PHQ-9 scores were obtained before and after surgery and these scores had to be within 30 days of each other. We utilized the Wilcoxon Matched Pairs Signed-Rank test to determine differences in the PHQ-9 scores prior to amputation and after amputation.  

Results  
Of the twenty patients in the retrospective cohort, 90% (18/20) had increased PHQ-9 scores within 30 days of amputation. The mean PHQ-9 scores were 3.65 and 12.35 before and after amputation (Figure 1), respectively (a difference of 8.7; p=0.0001). There were three major themes from the semi-structured interviews: depression, distress, and barriers to mental health care; non-traumatic amputations can be a traumatic experience for patients. We coined these results as Diabetes-Related Extremity Amputation Depression & Distress (DREADD).  

Discussion 
DREADD is a potentially dangerous complication of diabetes mellitus. Non-traumatic amputations can be a traumatic experience for patients. Surgeons should screen their patients with T2DM before and after any non-traumatic amputation and make the appropriate referral if necessary. Psychiatrists and other metal health clinicians should be included in multidisciplinary limb preservation teams.