212 Participants Needed

Topical Wound Oxygen Therapy for Leg Ulcers

(VaLUe I Trial)

DH
Overseen ByDespina Herodotou, MRCPod, DABPMi
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers. Participants will utilize standard of care (SOC) multilayer compression dressings with an inactive wound contact layer. Following a 2-week run-in period with SOC and after meeting all eligibility criteria, subjects will be randomized in a 1:1 ratio with TWO2 therapy or sham control therapy plus SOC. Participants will enter the intervention period of up to 16-weeks, followed by a long-term follow-up period of 52 weeks post randomization.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications like systemic steroids over 10mg daily or immunosuppressive agents, these might interfere with the study treatment, so it's best to discuss with the study team.

Is topical wound oxygen therapy safe for humans?

Topical wound oxygen therapy is considered safe for humans, as it does not have the risks associated with systemic oxygen toxicity and no complications were reported in studies involving its use for wound healing.12345

How does Topical Wound Oxygen Therapy differ from other treatments for leg ulcers?

Topical Wound Oxygen Therapy is unique because it delivers oxygen directly to the wound site, which can help promote healing by improving oxygen availability in the tissue. Unlike systemic oxygen therapies, it is non-invasive, can be administered at home, and does not carry the risk of oxygen toxicity.12367

What data supports the effectiveness of the treatment Topical Wound Oxygen Therapy for Leg Ulcers?

Research suggests that topical oxygen therapy can help heal difficult wounds, like diabetic foot ulcers and pressure ulcers, by reducing wound size and improving healing. Although more high-quality studies are needed, some evidence shows it may be a useful second option when other treatments don't work.26789

Who Is on the Research Team?

MG

Mike Griffiths, DProf, DMS, CRT, FCMI

Principal Investigator

AOTI Ltd.

AH

Anil Hingorani, MD

Principal Investigator

WT

Wael Tawfick, MB.BCH, MRCSI.

Principal Investigator

University of Galway

Are You a Good Fit for This Trial?

This trial is for individuals with chronic venous leg ulcers who have been using standard multilayer compression dressings. Participants must complete a 2-week period with these dressings before starting the trial and meet all other requirements.

Inclusion Criteria

My wound area totals 50cm2 or less.
My ulcer has been present for 6 weeks to 5 years.
I have a long-lasting leg ulcer below the knee due to vein problems.
See 7 more

Exclusion Criteria

My wound exposes bone, muscle, or tendon.
NYHA Class IV
I had surgery to improve blood flow in my limb within the last month.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants undergo a run-in period with standard of care (SOC) multilayer compression dressings

2 weeks

Treatment

Participants receive either TWO2 therapy or sham control therapy plus SOC for up to 16 weeks

16 weeks
Bi-weekly clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sham Control Topical Wound Oxygen
  • Topical Wound Oxygen Therapy
Trial Overview The study tests Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy against a sham control therapy, both in addition to standard care. Patients are randomly assigned to either real or sham treatment for up to 16 weeks, followed by a year of follow-up.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Topical Wound Oxygen Therapy DeviceActive Control1 Intervention
Topical Wound Oxygen (TWO2) device in combination with the extremity chamber delivers oxygen and cyclical compression to the wound site. The sealed environment created by the extremity chamber is filled with oxygen for a minimum of 120 minutes, 5 times a week over multilayered compression dressings and a wound contact layer.
Group II: Sham Control Topical Wound Oxygen (TWO2) devicePlacebo Group1 Intervention
A Sham Control Topical Wound Oxygen (TWO2) device in combination with the extremity chamber that does not deliver oxygen and cyclical compression to the wound site. The sealed environment created by the extremity chamber is filled with room air for a minimum of 120 minutes, 5 times a week over multilayered compression dressings and a wound contact layer.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AOTI Ltd.

Lead Sponsor

Trials
3
Recruited
310+

Published Research Related to This Trial

Topical oxygen therapy is a promising treatment option for difficult-to-heal lower extremity wounds, supported by various in vitro, preclinical, and clinical data.
While randomized controlled trials are still needed, current evidence suggests that it can be used as a second-line therapy for patients with refractory wounds, with specific protocols for administration and patient management provided.
Evidence-based recommendations for the use of topical oxygen therapy in the treatment of lower extremity wounds.Gordillo, GM., Sen, CK.[2022]
In a double-blind randomized controlled trial involving patients with chronic diabetic foot ulcers (DFUs), the use of multimodality cyclical pressure Topical Wound Oxygen (TWO2) therapy significantly improved healing rates, achieving a closure rate of 41.7% compared to 13.5% in the sham control group at 12 weeks.
At 12 months, 56% of ulcers in the TWO2 therapy group were closed, compared to only 27% in the control group, indicating that TWO2 therapy is an effective adjunctive treatment for refractory DFUs that have not healed with standard care.
A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study.Frykberg, RG., Franks, PJ., Edmonds, M., et al.[2021]
A small evaluation involving 18 patients with pressure ulcers showed that topical oxygen therapy, using a haemoglobin spray, led to wound healing progression in all cases and significant size reduction in 17 out of 18 wounds.
This therapy is easy to use, requiring no special training, and can be applied in any care setting, highlighting its potential as an effective intervention for managing chronic pressure ulcers.
A topical haemoglobin spray for oxygenating pressure ulcers: a pilot study.Tickle, J.[2015]

Citations

Evidence-based recommendations for the use of topical oxygen therapy in the treatment of lower extremity wounds. [2022]
A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study. [2021]
A topical haemoglobin spray for oxygenating pressure ulcers: a pilot study. [2015]
Topical oxygen therapy in acute traumatic musculoskeletal wounds of the foot and ankle. [2023]
Does topical wound oxygen (TWO2) offer an improved outcome over conventional compression dressings (CCD) in the management of refractory venous ulcers (RVU)? A parallel observational comparative study. [2016]
Evidence-based practice standards for the use of topical pressurised oxygen therapy. [2021]
Topical oxygen as an adjunct to wound healing: a clinical case series. [2022]
Adjunctive topical oxygen therapy for wound healing in patients with peripheral arterial disease. [2023]
Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security