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

NCT07747896 | Recruiting DMC

• 1 other identifier: H-26016816
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Infection; Diabetic Foot Ulcer (DFU); Ulcer; Hard to Heal Wounds; Diabetic Foot Disease

Keywords

Diabetic Foot Ulcer; MDT; Hard-to-heal ulcer; Cross Sectional Collaboration

Outcome Measures

Primary Outcomes (1)

• Ulcer healing

  Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms

  Ulcer healing at 12 months

Secondary Outcomes (13)

• Time to ulcer healing

  12 moths

• Ulcer recurrence

  12 months

• Infections

  12 months

• Amputations

  12 months

• Visits

  12 months

Study Arms (2)

coordinated primary-care-based MDT-model

EXPERIMENTAL

The 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 healing, the participant is pla

Other: coordinated primary-care-based MDT-model

Standard Care

ACTIVE COMPARATOR

Participants 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.

Other: Standard Care (in control arm)

Interventions

coordinated primary-care-based MDT-model OTHER

The 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

coordinated primary-care-based MDT-model

Standard Care (in control arm) OTHER

Participants 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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Frederikssund Municipality, Denmark: collaborator

Study Sites (1)

North Zealand Hospital

Hillerød, 3400, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jonas Askø Andersen, Md Phd Clin Assoc Prof

CONTACT

+4548297451; jonas.hedegaard.andersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Phd Clin Assoc Prof

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

DK (1)