NCT04210609

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vaporox · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Vaporous Hyperoxia Therapy	55 minutes of treatment, 2 times per week

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2019-12-24
• Last updated: 2021-10-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study