Recruiting

Carbothera

Sponsor:

University of Manitoba

Code:

NCT02239419

Conditions

Critical Lower Limb Ischemia

Critical Limb Ischemia

Foot Ulcer

Skin Ulceration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CO2-Enriched Tap Water (Carbothera)

Non-CO2-Enriched Tap Water

Study Details

Brief summary:

Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease. Patients with kidney disease receiving dialysis have an increased prevalence of critical limb ischemia. Carbon dioxide (CO2) foot bathing has been reported to improve subcutaneous microcirculation. The proposed clinical study will evaluate the therapeutic potential of CO2 enriched water (produced by the Carbothera device) on treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis. Forty individuals how have a distal extremity ulcer who are currently undergoing hemodialysis will participate in this study.

Conditions

Critical Lower Limb Ischemia

Critical Limb Ischemia

Foot Ulcer

Skin Ulceration

Study ID

NCT02239419

Start date

Sep, 2014

Status verified date

Sep, 2014

Completion date

Dec, 2016

Anticipated

Primary completion date

Apr, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male and female participants ≥ 18 years of age with at least one distal extremity ulcer (arterial ischemic ulcer).
2. No acute medical illness and on conventional medical management prior to Carbothera.
3. Willingness and ability to provide written informed consent

Exclusion Criteria:

1. DVT or PE within 12 months.
2. Subjects with known active cancer, HIV, hepatitis B virus, hepatitis C virus, human transmissible spongiform encephalopathy, Treponema pallidum.
3. Subjects who are deemed to have an infection of the distal extremity ulcer.
4. Women who are pregnant
5. Unstable angina.
6. Acute MI within 1 month.
7. Stroke within 1 month.
8. Patient scheduled for revascularization during the 4-month intervention period.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CO2-Enriched Tap Water (Carbothera)

CO2-enriched tap water (CO2 concentration, 1000-1200 ppm) maintained at a temperature of 37˚C. Tap water will be enriched with CO2 by the investigational Carbothera device.

placebo comparator: Non-CO2-Enriched Tap Water

Non-CO2-enriched tap water (i.e. normal tap water) maintained at a temperature of 37˚C.

Interventions

CO2-Enriched Tap Water (Carbothera)

Participants will undergo foot bathing with CO2-enriched tap water (CO2 concentration, 1000-1200 ppm) maintained at a temperature of 37˚C with an immersion time of 15 mins, 3 times per week for 4 consecutive months. Participants will be rested on a chair for 15 min before foot bathing. If participant is undergoing hemodialysis, foot bathing will occur prior to their routine hemodialysis procedure.

Non-CO2-Enriched Tap Water

Participants will undergo foot bathing with non-CO2-enriched tap water maintained at a temperature of 37˚C with an immersion time of 15 mins, 3 times per week for 4 consecutive months. Participants will be rested on a chair for 15 min before foot bathing. If participant is undergoing hemodialysis, foot bathing will occur prior to their routine hemodialysis procedure.

Primary outcome measure

  • Changes in Ulceration Area, Volume, Depth and Rate [ Time Frame: 4 months ]
  • Changes in Ankle Brachial Index (ABI)/Blood Flow [ Time Frame: 4 Months ]

Central Contacts and Locations

Central contacts

Paramjit Tappia, PhD

204-258-1230ptappia@sbrc.ca

Amarjit S Arneja, MD

204-787-2270aarneja@exchange.hsc.mb.ca

Locations

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Paramjit Tappia, PhD

204-258-1230ptappia@sbrc.ca

Bram Ramjiawan, PhD

204-235-3372bramjiawan@sbgh.mb.ca

Principal Investigator:

Chris Sathianathan, MD

Health Sciences Centre- Rehabilitation Hospital

Recruiting

Winnipeg, Manitoba, Canada, R3A 1A4

Contacts

Amarjit S Arneja, MD

204-787-2270

Principal Investigator:

Amarjit S Arneja, MD

More Information

Sponsor

University of Manitoba

Last update posted

Oct 30, 2015

Last verified

Sep, 2014

Keywords

  • Critical Limb Ischemia
  • Limb Ischemia
  • Wound Care
  • Hemodialysis
  • Dialysis
  • Skin Ulceration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2015-10-30.