Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— TWO2DFU  

Official title:

A Multi-national, Multi-center, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate the Efficacy of HyperBox Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02326337
• Other study ID #: AOTI- TWO2DFU-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 19, 2014
• Last updated: February 19, 2018
• Start date: October 2014
• Est. completion date: December 15, 2018

Study information

• Verified date: February 2018
• Source: AOTI Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.

Description:

Subjects meeting the initial eligibility criteria will enter a 2 week run-in period with a standardized off-loading device, advanced moist wound therapy (AMWT) dressings and will receive sharp debridement. Subjects with wounds that do not decrease more than 30% at the end of the 2 week run-in period and where all other eligibility criteria are met, will be randomized to either the TWO2 device arm, or sham (placebo) device arm.

All subjects will use the TWO2/Sham device for 90 minutes a day at their home or nursing care facility 5 times a week for the treatment phase of up to 12 weeks. Monitoring of the wound will take place with weekly clinic visits for safety and compliance assessment and documentation. Weekly wound photographs and measurements will be taken. Wounds that close at, or before, 12 weeks will continue to use TWO2/sham device, off-loading and AMWT and have an additional visit two weeks later to confirm wound closure. All subjects whether healed or not will enter a follow up period of an additional 12 and 38 weeks.

The maximum duration for participation in the trial is 54 weeks. During the follow-up phase, subjects will receive standard care according to the clinician's recommendation and will be asked not to participate in another wound care trial during this period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: December 15, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Subject has a documented diagnosis of Diabetes mellitus Type 1 or 2

• Foot ulcer at or below ankle with duration of more than 4 weeks but no longer than 1 year

• If the index ulcer is a post amputation wound date of surgery must be > 30 days

• 2 week run in period with less than 30% wound size reduction

• University of Texas Grade 1A, 1B, 1C, 1D, 2A, 2B, 2C, or 2D (Appendix I)

• Ulcer is = 1cm2 and = 20cm2 after debridement at start of run-in period

• If more than one ulcer is present on the foot, only the largest is considered in the study (Index ulcer)

• Index ulcer must be = 1cm away from any other ulcers present on the foot

• Adequate perfusion with ABI > 0.7 And TcpO2 > 30mmHg OR skin perfusion > 30mmHG OR Toe pressure > 30mmHg OR Duplex with biphasic waveforms below the knee

• No planned revascularization procedure or vascular surgery within the last/next 30 days

• Subject and/or caregiver are willing and able to comply with all specified care and visit requirements

• Subject has a reasonable expectation of completing the study; according to the Investigator's clinical judgment

Exclusion Criteria:

• Evidence of gangrene on any part of affected limb

• Documented evidence of osteomyelitis on any part of affected limb

• Index ulcer has exposed bone

• Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention

• Active Charcot foot on the study limb

• Subject participated in another investigational device, drug or biological trial within last 30 days

• Uncontrolled diabetes: HbA1c > 12 %

• Renal dialysis or creatinine > 2.5

• Known immune insufficiency

• Chronic steroid use or immunosuppressive agents within the last three (3) months or is anticipated to require them during the course of the study

• Active treatment for malignancy (not specific to study limb)

• Patient has a Deep Vein Thrombosis within the last 30 days

• Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within the screening period

• Subject may not be pregnant at the time of treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• TWO2 Device
Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
• Placebo Device
Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.

Locations

Country	Name	City	State
France	Avicenne Hospital	Bobigny
France	Hospital Simone Veil	Eaubonne
France	Montpellier University Hospital	Montpellier
Germany	Städtisches Klinikum Dessau	Dessau
Luxembourg	Kirchberg Hospital	Luxembourg
United Kingdom	Northwick Park Hospital	Harrow
United Kingdom	King's College Hospital	London
United States	Edward Hines, Jr. VA Hospital	Chicago	Illinois
United States	The Research Center Inc.	Hialeah	Florida
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
United States	Advanced Research Institute of Miami	Miami	Florida
United States	Advanced Research Institute of Miami	Miami	Florida
United States	Carl T. Hayden VA Medical Center	Phoenix	Arizona
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Salem VA Medical Center	Salem	Virginia
United States	NorthBay Center for Wounds	Vacaville	California
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AOTI Ltd.

Countries where clinical trial is conducted

United States,  France,  Germany,  Luxembourg,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound closure within 12 weeks with the use of Topical Wound Oxygen Therapy (TWO2)	Incidence of complete wound closure defined as 100% skin re-epithelialization without dressing requirements which is confirmed by 2 consecutive study visits 2 weeks apart.	12 weeks
Secondary	Time to complete wound closure	Wounds not closed at the end of the12 week treatment phase are assessed for 100% skin re-epithelialization without dressing requirements at a study visit or by telephone call and review of medical record after a further 12 and 26 weeks .	54 weeks
Secondary	Change in wound size over time	Wound size will be documented at study visits by the use of digital photography and wound-mapping software.	54 weeks
Secondary	Incidence of recurrence	Wounds that are documented as closed will be assessed for recurrence at a study visit or by telephone call and review of medical records at 12 and 26 weeks after the treatment phase.	54 weeks
Secondary	Incidence of amputation	Incidence of amputation will be documented throughout the study	54 weeks
Secondary	Incidence of adverse device effects	Incidence of adverse device effects will be documented throughout the study	54 weeks
Secondary	Quality of Life Assessment	Quality of Life is a composite outcome measure assessed by the use of a Visual Analogue Scale to document level of pain and the Cardiff Wound Impact Schedule questionnaire.	54 weeks
Secondary	Economic Analysis	Economic Analysis is a composite measure of the wound before the study (up to one year) and for the duration of the study. The assessment is obtained by documenting treatment history of the wound that includes types of dressings used, time taken for dressing changes, by whom dressings are changed, and type and duration of hospitalization as well as the administration of the EQ-5D questionnaire at the Baseline visit, weeks 4, 8 and 12 on treatment and 12 and 26 weeks post treatment.	54 weeks