Does Applying More Oxygen Cure Lower Extremity Sores?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28958

Enrollment

275

Registered

2013-04-09

Start date

2013-07-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic ischemic ulcers

Interventions

Patients are placed in an airtight cabin and receive 100% 2.5 ATA. A complete course of HBOT treatments involves 40 sessions, once daily, for 90 minutes. The control group will receive wound care as

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type I or II diabetes 2. Wagner 2, 3 or 4 lower extremity ulcer(s), present for at least 4 weeks. In case more than one ulcer is present, the largest will be observed as target ulcer. 3. Leg ischemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg 4. Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intra-arterial digital subtraction angiography of the ipsilateral leg 5. Age ≥ 18 years 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous major amputation of the leg with the index ulcer 2. Chronic Obstructive Pulmonary Disease (COPD) GOLD IV 3. Current treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids (daily 10mg or more), as this interferes with normal wound healing 4. End stage renal disease requiring dialysis 5. Metastatized malignancy 6. Left ventricular failure with ejection fraction (EF) <20% or external pacemaker 7. Pregnancy 8. Insufficient proficiency of Dutch language, or unability to complete the Dutch questionnaires or not compos mentis.

Design outcomes

Primary

Measure	Time frame
Wound healing and limb salvage.	—

Secondary

Measure	Time frame
1. Pain scores (10-point VAS scale); 2. Feedom of minor amputations (i.e. toe or metatarsal); 3. Number of additional vascular interventions; 4. Transcutaneous oxygen pressure (TcpO2); 5. Quality of life (ALDS, SF36, Vascuqol, and EQ-5D); 6. Patients out-of-pocket costs related to additional medication, travel expenses, etc; 7. Recurrence of the target ulcer and the occurrence of new ulcers; 8. Costs related to HBOT and conventional treatment; 9. Safety.	—

Measure

Time frame

1. Pain scores (10-point VAS scale); 2. Feedom of minor amputations (i.e. toe or metatarsal); 3. Number of additional vascular interventions; 4. Transcutaneous oxygen pressure (TcpO2); 5. Quality of life (ALDS, SF36, Vascuqol, and EQ-5D); 6. Patients out-of-pocket costs related to additional medication, travel expenses, etc; 7. Recurrence of the target ulcer and the occurrence of new ulcers; 8. Costs related to HBOT and conventional treatment; 9. Safety.

—

Contacts

Public ContactD.T. Ubbink

Academic Medical Center (AMC), Department of Clinical Epidemiology and Biostatistics, P.O. Box 22660

d.ubbink@amc.uva.nl+31 (0)20 5666892

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)