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

Vaporox

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Device: Vaporous Hyperoxia Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04210609

VAPOROX-VHT100-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

VHT treatment

Experimental group

Description:

Patients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week

Treatment:

Device: Vaporous Hyperoxia Therapy