Non-Healing Ulcers Without Critical Limb Ischemia (NEWLI)

This is an interventional treatment trial for Peripheral Artery Disease Without Critical Limb Ischemia focused on measuring peripheral artery disease, endovascular procedure, non-healing ulcer Read More

Inclusion Criteria:

1. Patients need to be at least 18 years old

2. Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer.

   - Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months.

   • Patients will be hospitalized in the Dermatology inpatient clinic.
   • Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization.

3. Before inclusion in the study, patients must undergo complete angiological diagnostic work-up including:

   • A baseline ABI, toe pressure and tcPO2 measurements,
   • A non-invasive arterial imaging including an angio-CT scan or an angio-MRI,

4. The non-invasive arterial work-up must revel mild to moderate PAD, without any criteria or sign of CLI (see flow-chart):

   • Ankle pressure ≥ 50 mmHg,
   • + ABI: < 0.9 or > 1.3,
   • ± Toe pressure : 30-100 mmHg
   • ± tcPO2: 20-40 mmHg,
   • At this moment the patient may be included in the study protocol.

5. All patients presenting with mild to moderate PAD and evidence of at least 1 impaired arterial vessel targeting the ulcer will initially undergo conservative impatient clinic care for at least 2-4 weeks and benefit from at least 1 thin skin autograft.

   • Persisting surface of lower limb ulcers will be assessed 1 month later:

     -- In the presence of a healed ulcer surface > 70%, the patient will undergo 6 months of clinical follow up at 1-3-6 months.

     1. In case of persistence of healed ulcer surface > 70% clinical success will be achieved.

     2. In presence of healed ulcer surface < 70% the patient will undergo a new angiological work-up.

   • If mild to moderate PAD will be again outlined the patient will join the < 70% healed ulcer group.

   • On the other hand, if CLI will be pointed out lower limb revascularisation and at least one thin skin autograft will be performed.

     -- In presence of a healed ulcer surface < 70%, endovascular PTA and at least one thin skin autograft will be performed. The ulcers healing will then be monitored at 1-3-6 months and persisting ulcers surface re-assessed:

   • in presence of an healed ulcer surface > 70% clinical success will be achieved,
   • if presence of an healed ulcer surface < 70% clinical failure will be retained.

Exclusion Criteria:

1. Patients who refused to give their written informed consent.
2. Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n°2).
3. Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 - < 1.3, TP > 100mmHg, tcPO2 > 40mmHg).

4. Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer:

   - Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.).

5. Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal):

   - In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization.

6. Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety:

   • Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy,
   • Too complex arterial disease or anatomy, in which the estimated procedural technical success rate is < 50% (i.e. complex chronic total occlusion).
7. Patients in whom an amputation is unavoidable, despite any revascularization attempt (e.g. extensive skin necrosis [Rutherford class 6]), - If, it will be estimated that, a successful revascularization procedure may reduce the level of amputation, or if a successful intervention may improve the amputation's healing process, the patient may be included in the study.