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

Study acronym: TSS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
5,087 trials monitored
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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.
Trial Details
NCT Number NCT07747896
Lead Sponsor Nordsjaellands Hospital
Collaborators: Frederikssund Municipality, Denmark
Conditions
(from sponsor)
Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Ulcer (DFU), Ulcer, Hard to Heal Wounds
Related terms Diabetic Foot, Ulcer
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov