To assess the relative effectiveness of HBOT as an adjunct to standard wound care in terms of preventing amputations and improving wound healing in ischemic diabetic ulcers, and its cost-effectiveness. Secondary objectives are to assess the patients…
ID
Source
Brief title
Condition
- Skin vascular abnormalities
- Therapeutic procedures and supportive care NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are freedom of major (above ankle) amputations after 12
months, and achievement of, and time to, complete wound healing.
Secondary outcome
Secondary endpoints are pain scores, freedom of minor amputations after 12
months, TcPO2, quality of life, costs, need for vascular interventions and
safety. Moreover, markers of wound healing, coagulation and oxidative stress
will be assessed to investigate the possible working mechanisms of HBOT.
Background summary
Chronic ischemic leg ulcers in diabetic patients pose a major health care
problem. Conventional treatment is complex and costly. The effectiveness of
hyperbaric oxygen therapy (HBOT) as an adjunct to standard wound care is
promising, although the evidence comes from small trials with heterogenous
populations and interventions. Also, the cost-effectiveness of HBOT is still
unclear.
Study objective
To assess the relative effectiveness of HBOT as an adjunct to standard wound
care in terms of preventing amputations and improving wound healing in ischemic
diabetic ulcers, and its cost-effectiveness.
Secondary objectives are to assess the patients* quality of life and the need
for vascular interventions in both treatment arms.
Study design
Multicenter randomized clinical trial.
Intervention
Patients will be randomly assigned to standard (vascular surgical and local
wound) care with or without HBOT. HBOT will comprise 40 sessions, 90 minutes
each, at 2.5 ATA over an eight-week period.
Study burden and risks
All patients, irrespective of their allocation, will receive standard treatment
consisting of endovascular or surgical revascularization (if possible) and
local wound care. HBOT is a generally accepted treatment in non-healing wounds.
The risks of HBOT are low. Patients in the HBOT group will receive a regular
treatment regimen of 40 sessions of 90 minutes of HBOT in 8 weeks. Patients
will be asked to fill in questionnaires at four time points, and to keep track
of pain scores weekly during the first 8 weeks. Three visits to their
outpatient surgical clinic will be scheduled, and will not deviate from usual
care. The subset of 40 patients presenting at the AMC will be additionally
asked to collect 24-hour urine and will be subjected to a punch biopsy of the
wound edge and venous blood collection at two points in time.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Type I or II diabetes
2. Wagner 2, 3 or 4 lower extremity ulcer(s), present for at least 4 weeks
3. Leg ischemia defined as: highest ankle systolic blood pressure < 70 mmHg or toe systolic pressure < 50 mmHg or TcpO2 < 40 mmHg
4. Complete assessment of peripheral arterial lesions from the aorta to the tibial arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography or intra-arterial digital subtraction angiography of the ipsilateral leg
5. Age * 18 years
6. Written informed consent
Exclusion criteria
1. Previous major amputation of the leg with the index ulcer
2. COPD GOLD IV
3. Current treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids (daily 10mg or more)
4. Eind-stadium nierfalen, waarvoor dialyse nodig is
5. Metastatized malignancy.
6. Left ventricular failure with EF <20% of externe pacemaker
7. Pregnancy
8.Insufficient proficiency of Dutch language, or unability to complete the Dutch questionnaires, or not compos mentis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44429.018.13 |
| Other | Pending |
| OMON | NL-OMON28958 |