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.
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
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
Parallel
coordinated primary-care-based MDT-model
Other interventionThe proposed intervention consists of an MDT with an orthopedic surgeon (Jonas Askø Andersen) and a wound care nurse from the wound clinical at North Zealand Hospital as well as a wound care nurse from the primary sector. Participants who are randomized to intervention is offered treatment in the team as deemed appropriate by the MDT. The participant will be seen in the clinic (in the primary sector) for planned study visits at. 1\. Week 1 2. Week 4 3. 3 months 4. 6 months 5. 12 months 6. Extra study visits can be planned as deemed necessary for the individual participant between the above outlined visits Weekly visits in the clinic for bandage changes and standard wound care is planned as deemed relevant by the MDT team for the individual participant. The visits are performed by wound care nurses in the primary sector If any outcomes relevant for the study occurs outside of the planned study visits i.e., ulcer healing, infections or recurrence following
Standard Care (in control arm)
Other interventionParticipants randomized to control are not invited to be seen by the MDT team but are attended by the wound care nurse from the primary sector as part of the standard treatment offered to individuals with ulcers in the municipality. Apart from planned visits at 3, 6 and 12 months, the frequency and number of visits in the study period is performed as deemed appropriate by the wound care nurses from the primary sector. If any outcomes relevant for the study occurs outside of the planned study visits i.e., ulcer healing, infections or recurrence following healing date of event is noted.
Ulcer healing
Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms
Time to ulcer healing
Mean time (in days) to healing of healed hard-to-heal ulcer(s) in days - compared between groups
Ulcer recurrence
Incidence of recurrence of ulcer following healing of hard-to-heal ulcer(s) - compared between groups
Infections
Incidence of infections divided in * Infection treated with tablet antibiotic * Infection treated with intravenous antibiotics, admittance to hospital and/or surgery Compared between groups
Amputations
Incidence and amputations in total and divided in * Below ankle amputation * Above ankle amputations Compared between groups
Click on the lead sponsor to view all of their trials.
Nordsjaellands Hospital
Lead sponsor
Frederikssund Municipality, Denmark
Collaborator
