Coordinated primary-care MDT approach for hard-to-heal ulcers
Official title: Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers; a Randomized Clinically Controlled Trial
Run by Nordsjaellands Hospital · NCT07747896 · Data updated 2026-11-12
A group of adults with hard-to-heal diabetic foot ulcers will be randomly assigned to standard care or a coordinated multidisciplinary team to see if the team approach helps ulcers heal better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 1 site (Hillerød) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | October 31, 2028 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07747896 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with hard-to-heal ulcers who can understand information and adhere to planned visits, and who speak Danish or English.
✕Probably not a fit
Patients unlikely to benefit include those needing imminent surgical treatment, with very low toe pressures, or unable to participate in regular follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial compares a multidisciplinary, primary-care–based team model with standard care for hard-to-heal ulcers. Patients are followed for 12 months with six fixed clinic visits and additional visits as needed. The primary outcome is the number of ulcers healed, with several secondary measurements of care processes and patient status. No new drugs or surgeries are introduced; the intervention focuses on how care is organized and delivered across hospital wound clinics and primary care nurses.
Why it matters
Potential benefit: If successful, patients may experience faster or more complete healing of hard-to-heal ulcers through improved coordination of care.
How similar studies have gone: Previous work in MDT and cross-sector collaboration has shown promise in wound healing, but evidence specifically for coordinated primary-care MDT models in hard-to-heal ulcers remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
North Zealand Hospital
Hillerød, Denmark Recruiting
Study contacts
- Study coordinator: Jonas Askø Andersen, Md Phd Clin Assoc Prof
- Email: jonas.hedegaard.andersen@regionh.dk
- Phone: +4548297451
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Continuous temperature monitoring of the feet with connected insoles and a smartphone app in adults with diabetes at high risk
This trial tests whether the Solsius SelfCare system can reliably flag pre-ulcer foot changes in adults with diabetes by detecting temperature differences between feet for at least two consecutive days.
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Wound matrix treatments for nonhealing diabetic foot ulcers
This trial will test whether adding special wound matrix products to standard care helps close hard-to-heal diabetic foot ulcers in adults with type 1 or 2 diabetes within 12 weeks.
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DiaFootCare: a mobile app to help adults with diabetic foot ulcers manage self-care in Oman
A mobile app called DiaFootCare will be tested to see if it helps adults with diabetic foot ulcers in Oman take better care of themselves and improve healing compared with usual care.
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Wound gel for diabetic foot ulcers compared with standard care
This study tests whether the investigational VES-0-D wound gel helps heal mild to moderate diabetic foot ulcers better than standard treatment.
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High-Purity Collagen Skin Substitute vs Fish Skin Matrix for Diabetic Foot Ulcers
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.