Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds (VHT1)

Vaporox

Status: Completed

Conditions: Foot Ulcer; Neuropathic Foot Ulcer

Treatments: Device: Vaporous Hyperoxia Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04244201

VAPOROX-VHT100-01

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.

Full description

The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
• University of Texas Health Science Center classification: Grade 0, 1, and 2

Exclusion criteria

• Ulcers above the medial and lateral malleoli
• Etiology of cancer/neoplastic
• Etiology of collagen vascular disease
• Etiology of gangrene
• Etiology of osteomyelitis (Grade 3)
• Etiology of thermal burns
• Etiology of radiation injury
• Pregnancy
• Acute skin conditions
• Inadequate perfusion to support treatment
• Wounds where the end cannot be probed
• Wounds covered with petroleum based dressing
• Non-compliant patients

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

VHT treatment

Experimental group

Description:

Patients will be treated with VHT for 1 hour four times per week

Treatment:

Device: Vaporous Hyperoxia Therapy