Does Applying More Oxygen Cure Lower Extremity Sores?

• Conditions: ischemie; leg ulcer; perifeer vaatlijden; ischaemia; Diabetic ischemic ulcers; peripheral vascular disease; Diabetische ulcera

• Registration Number: NL-OMON28958
• Lead Sponsor: AMC, Amsterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 275

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.

Exclusion Criteria

1. Previous major amputation of the leg with the index ulcer

2. Chronic Obstructive Pulmonary Disease (COPD) GOLD IV

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound healing and limb salvage.

Secondary Outcome Measures

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