About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- coordinated primary-care-based MDT-model
- Standard Care (in control arm)
Treatment groups
Sponsors and collaborators
Nordsjaellands Hospital
Lead sponsor
Frederikssund Municipality, Denmark
Collaborator