Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers (VHTDFU2)

Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Vaporous Hyperoxia Therapy

Detailed Description

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. VHT treatments will be provided as an adjunct to standard wound care. Subjects will receive VHT treatments until wound closure, or for the treatment period of 20 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Rock Canyon Foot and Ankle Clinic
    • Denver, Colorado, United States, 80033
      • Rocky Mountain Foot and Ankle Center
    • Denver, Colorado, United States, 80210
      • Colorado Foot and Ankle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3
• Wound has resisted healing with standard wound care for at least 6 weeks
• No symptoms of sepsis
• Able to maintain reasonable nutrition and hydration
• Able to maintain adequate home care between treatment visits
• Able to understand and follow basic wound care instructions, or has caregiver who can assist

Exclusion Criteria:

• Skin wounds cancer/neoplastic etiology
• Wounds that involve osteomyelitis or tendon involvement
• Diagnosis of methicillin resistant staph aureus by wound swab
• Acute skin conditions
• Surgery within 30 days of study onset
• Wounds where the end cannot be probed
• Participation in another clinical trial within 120 days prior to study onset
• Non-compliant patients
• Pregnancy
• Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VHT treatment; Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week	Device: Vaporous Hyperoxia Therapy; 55 minutes of treatment, 2 times per week; Other Names: VHT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound closure rate at 20 weeks	The percentage of subjects that achieved complete wound closure by week 20, where wound closure is defined by complete re-epithelialization without drainage	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound closure rate at 12 weeks	The percentage of subjects that achieved complete wound closure by week 12, where wound closure is defined by complete re-epithelialization without drainage	12 weeks
Time to 50%, 75%, 100% wound closure	Time to percent reduction in volume (length x width x depth) from baseline	Up to 20 weeks

Collaborators and Investigators

• Sponsor: Vaporox
• Investigators: Principal Investigator: Dustin Kruse, DPM, Rocky Mountain Foot and Ankle Center

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Anticipated): October 3, 2022
• Study Completion (Anticipated): October 3, 2022

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Signs and Symptoms, Respiratory; Diabetic Foot; Foot Ulcer; Hyperoxia
• Other Study ID Numbers: VAPOROX-VHT100-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes