Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers

The TSS project is a study of the effects of treating hard-to-heal ulcers in a multidisciplinary cross sectional team, meaning that nurse and doctor from a hospital based wound healing clinic and wound care nurse from the primary care sector treat the patient in collaboration rather than the current form where care in municipalities and hospital setting, communicate but treat the patient on their own. The study is designed as a randomized study, meaning that individuals with hard-to-heal ulcers are randomly designated to standard care or the multidis-ciplinary team. We measure several aspects of the new format, but the main outcome com-pared between the two groups (standard care and multidisciplinary care) is number of ulcers healed. Participants are followed for a year after inclusion in the study, and have 6 fixed visits in the clinic, with the possibility of more visits if necessary. There is no "new" medicine, surgery or other treatments planned in the study, but the multi-disciplinary team can offer and implement any treatment deemed appropriate for the individ-ual that is allocated to the multidisciplinary team, of course the individual has the opportunity to decline any treatment offered by the team. The control group, i.e. individuals allocated to standard care, will receive the treatment that is normally available to individuals with hard-to-heal ulcers treated in the municipality, including referral to hospital based treatments.

Inclusion Criteria: * Patients aged 18 years or above * Hard-to-heal ulcer(s) * Able to understand written and oral information * Ability to follow planned visits and treatment * Able to provide informed consent in Danish and/or English Exclusion Criteria: Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening * Toe blood pressure \< 35mmHg * Infections of the ulcer needing acute or sub-acute (defined as within seven days) surgical treatment * Prior major amputations on affected or contralateral leg * Current treatment with cytotoxic drugs or with systemically administered glucocorticoids * Likely inability to comply with the need for planned visits because of planned activities * Participation in another interventional ulcer-healing trial within the 4 weeks prior to screening * Prior enrolment in this trial * Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent