Clinical Trials Logo
  1. Home
  2. Diabetic Foot Ulcer
  3. NCT04210609
  4. Details
NCT04210609 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

— VHTDFU2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04210609
Other study ID # VAPOROX-VHT100-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 4, 2021
Est. completion date October 3, 2022

Study information
Verified date October 2021
Source Vaporox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date October 3, 2022
Est. primary completion date October 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Vaporous Hyperoxia Therapy
55 minutes of treatment, 2 times per week

Locations
Country Name City State
United States Rock Canyon Foot and Ankle Clinic Castle Rock Colorado
United States Colorado Foot and Ankle Denver Colorado
United States Rocky Mountain Foot and Ankle Center Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
Vaporox

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Time to 50%, 75%, 100% wound closure Time to percent reduction in volume (length x width x depth) from baseline Up to 20 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04497805 - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers Phase 2
Withdrawn NCT03675269 - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: N/A
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Withdrawn NCT05024656 - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers N/A
Terminated NCT02202668 - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers N/A
Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A
Recruiting NCT05417425 - Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers N/A
Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
Recruiting NCT05804097 - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? Phase 4

External Links