An interventional study of coordinated primary-care-based MDT-model and Standard Care (in control arm) in Diabetic Foot Disease, Diabetic Foot Infection and Diabetic Foot Ulcer (DFU), sponsored by Nordsjaellands Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Nordsjaellands Hospital · Not applicable, Interventional, and Treatment
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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
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.
Ulcer healing
Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms
Time frame: Ulcer healing at 12 months
Time to ulcer healing
Mean time (in days) to healing of healed hard-to-heal ulcer(s) in days - compared between groups
Time frame: 12 moths
Ulcer recurrence
Incidence of recurrence of ulcer following healing of hard-to-heal ulcer(s) - compared between groups
Time frame: 12 months
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
Time frame: 12 months
Amputations
Incidence and amputations in total and divided in * Below ankle amputation * Above ankle amputations Compared between groups
Time frame: 12 months
Visits
Number of visits to clinics due to hard-to-heal ulcer(s) - compared between groups
Time frame: 12 months
Hospital admissions
Days admitted to hospital due to hard-to-heal ulcer(s) - compared between groups
Time frame: 12 months
Patient related outcomes
Patient related outcomes (Wound-QoL) - compared between groups Wound-Qol is a PROM tool designed for patients living with chronic ulcers, and is scored on 17-items, from 0 to 4 for each item. The higher the score the worse the outcome. The scores are registered as a global score for all 17 items and divided in three subscales.
Time frame: 12 months
Cost effectiveness
Cost effectiveness of intervention will be assessed by comparing expenditures between intervention and control group at four levels; 1. Hospital based care: Calculated using yearly Diagnosis Related Group (DRG) rates determined by the Danish Health Data Authority, obtained from the Danish National Patient Register 2. Primary care: Calculated using fees paid to healthcare providers by the health management regions, including general practitioners, podiatrists, and other specialists in primary care. 3. Prescribed medication: Calculated as the total cost of medication, including any out-of-pocket expenses, obtained from the Danish National Prescription Registry 4. Municipal home care: Calculated based on the average number of minutes of home care provided weekly, summed to total monthly hours. These hours are multiplied by the average hourly cost found in the national database of municipal services Were cost are not directly discernable from the above mentioned data sources estimates of
Time frame: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (first given here) o Reach will be assessed using data available from Frederikssund Kommune on number of individuals with hard-to-heal ulcer(s) treated that can be reached with the cross-sectional MDT intervention in the municipality.
Time frame: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (second given here) o Effect will be assessed by the clinical outcomes described above i.e., ulcer healing, infection etc.
Time frame: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (third given here) o Adoption will be assessed on a local (NOHs catchment area), regional (the Capital Region of Denmark) and on a Danish level, by the number of clinics that have adopted the cross-sectional MDT model.
Time frame: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (fourth given here) o Implementation will be assessed by the proportion of eligible individuals with hard-to-heal-ulcers offered the MDT-approach in Frederikssund Kommune.
Time frame: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (fifth given here) o Maintenance will be assessed by how many of the clinics that have adopted the intervention actually maintain the intervention over time.
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Data from the study on an individual level may compromise the individuals rights, data that can be safely shared, can be shared on relevant request
Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 8 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Nordsjaellands Hospital