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

Foot Ulcer Clinical Trial

— VHT1  

Official title:

Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244201
• Other study ID #: VAPOROX-VHT100-01
• Status: Completed
• Phase: N/A
• Start date: June 6, 2005
• Est. completion date: October 4, 2007

Study information

• Verified date: January 2020
• Source: Vaporox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 4, 2007
• Est. primary completion date: March 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot Ulcer
• Hyperoxia
• Neuropathic Foot Ulcer
• Ulcer

Intervention

Device:
• Vaporous Hyperoxia Therapy
1 hour of treatment, 4 times per week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vaporox

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing rate at 12 weeks	The percent of subjects that achieved wound healing at 12 weeks	12 weeks
Secondary	Time to wound healing	Time to achieve complete wound healing	up to 12 weeks