|- candidate number||14696|
|- NTR Number||NTR3944|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-apr-2013|
|- Secondary IDs|| NL44429.018.13 CCMO|
|- Public Title||Does Applying More Oxygen Cure Lower Extremity Sores?|
|- Scientific Title||Does Applying More Oxygen Cure Lower Extremity Sores?|
|- hypothesis||The hypothesis is that HBOT will have additional beneficial effect in terms of wound healing and/or limb salvage over conventional (surgical or non-surgical) care for diabetic patients with leg ischaemia, with acceptable costs. |
|- Healt Condition(s) or Problem(s) studied||Ischemia, Limb ischemia, Diabetic ischemic ulcers|
|- 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||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
8. Insufficient proficiency of Dutch language, or unability to complete the Dutch questionnaires or not compos mentis.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2013|
|- planned closingdate||31-dec-2016|
|- Target number of participants||275|
|- 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 usual.
|- Primary outcome||Wound healing and limb salvage.|
|- Secondary outcome||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;
|- Timepoints||Patients in both groups will be monitored for 12 months after inclusion. Throughout the 8 week treatment phase, all patients collect data about pain scores and wound healing. The questionnaires (costs, ALDS, SF-36, VASQUOL and EQ-5D) will be send to the patients home adress, accompanied by a prepaid return envelope.
Subsequently follow-up is performed by the vascular surgeon after 8 weeks, 3 months, 6 months, 12 months and after any vascular intervention. During this visits at the outpatient clinic the surgeon will collect outcome measures as mentioned.|
|- Trial web site||www.damocles-trial.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. D.T. Ubbink|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D.T. Ubbink|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale:|
Chronic leg ulcers in diabetic patients pose a major health problem. Conventional treatment is complex and costly. Current evidence on the (cost-)effectiveness of hyperbaric oxygen therapy (HBOT) as an adjunct to standard wound care is equivocal because studies have been heterogenous and have included small numbers of patients. As a consequence, cost-effectiveness is still unclear.
The primary objective is to assess whether the effectiveness of HBOT as an adjunct to standard wound care in preventing amputations and improving wound healing in ischemic diabetic ulcers justifies its costs.
Secondary objectives are to assess the quality of life and the need for vascular interventions following both treatments.
Multicenter randomized controlled trial.
275 diabetic patients with ischemic leg ulcers.
Patients will be randomly assigned to HBOT plus usual wound care or usual wound care only. HBOT will comprise 40 sessions, 90 minutes each, over an eight week period.
Primary endpoints are freedom of major (above ankle) amputations after 12 months, and occurrence of and time to complete wound healing.
Secondary endpoints are pain scores, freedom of minor amputations after.
|- Main changes (audit trail)|
|- RECORD||9-apr-2013 - 1-jul-2013|