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

RecruitingNAAges 18 Years - anyAllNordsjaellands Hospital
NCT07747896 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • coordinated primary-care-based MDT-model
  • Standard Care (in control arm)
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Where

1 site
North Zealand Hospital
Hillerød, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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