Diabetic Foot DiseaseTSSNCT07747896
Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers
A study testing coordinated primary-care-based MDT-model in people with Diabetic Foot Disease and Diabetic Foot Infection, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Ulcer (DFU)
- What is being tested?
- coordinated primary-care-based MDT-model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
North Zealand Hospital
Hillerød, 3400
Jonas Askø Andersen, Md Phd Clin Assoc Prof, +4523258084, jonas.hedegaard.andersen@regionh.dk
About this study
Official title: Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers; a Randomized Clinically Controlled Trial
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 Disease, Diabetic Foot Infection, Diabetic Foot Ulcer (DFU), Ulcer, Hard to Heal Wounds
- Being tested
- coordinated primary-care-based MDT-model, Standard Care (in control arm)
- Keywords
- Diabetic Foot Ulcer, MDT, Hard-to-heal ulcer, Cross Sectional Collaboration
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coordinated primary-care-based MDT-modelOther
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.
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing
Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms
Measured: Ulcer healing at 12 months
Secondary outcomes (13)
Time to ulcer healing
Mean time (in days) to healing of healed hard-to-heal ulcer(s) in days - compared between groups
Measured: 12 moths
Ulcer recurrence
Incidence of recurrence of ulcer following healing of hard-to-heal ulcer(s) - compared between groups
Measured: 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
Measured: 12 months
Amputations
Incidence and amputations in total and divided in
- Below ankle amputation
- Above ankle amputations Compared between groups
Measured: 12 months
Visits
Number of visits to clinics due to hard-to-heal ulcer(s) - compared between groups
Measured: 12 months
Hospital admissions
Days admitted to hospital due to hard-to-heal ulcer(s) - compared between groups
Measured: 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.
Measured: 12 months
Cost effectiveness
Cost effectiveness of intervention will be assessed by comparing expenditures between intervention and control group at four levels;
- 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
- Primary care: Calculated using fees paid to healthcare providers by the health management regions, including general practitioners, podiatrists, and other specialists in primary care.
- Prescribed medication: Calculated as the total cost of medication, including any out-of-pocket expenses, obtained from the Danish National Prescription Registry
- 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
Measured: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (first given here)
- 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.
Measured: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (second given here)
- Effect will be assessed by the clinical outcomes described above i.e., ulcer healing, infection etc.
Measured: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (third given here)
- 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.
Measured: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (fourth given here)
- Implementation will be assessed by the proportion of eligible individuals with hard-to-heal-ulcers offered the MDT-approach in Frederikssund Kommune.
Measured: 12 months
RE-AIM
RE-AIM outcomes will be applied to assess implementation outcomes and is divided in five domains (fifth given here)
- Maintenance will be assessed by how many of the clinics that have adopted the intervention actually maintain the intervention over time.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Frederikssund Municipality, Denmark
- Responsible party
- Principal investigator, Jonas Askø Andersen, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747896
- Sponsor's protocol ID
- H-26016816
- Other IDs
- H-26016816
- Acronym
- TSS
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers; a Randomized Clinically Controlled Trial
- ClinicalTrials.gov ID
- NCT07747896
- Acronym / sponsor ID
- TSS / H-26016816
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Ulcer (DFU), Ulcer, Hard to Heal Wounds
- Keywords
- Diabetic Foot Ulcer, MDT, Hard-to-heal ulcer, Cross Sectional Collaboration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Frederikssund Municipality, Denmark
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coordinated primary-care-based MDT-model | Experimental | Other: coordinated primary-care-based MDT-modelThe 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 |
| Standard Care | Active comparator | Other: Standard Care (in control arm)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coordinated primary-care-based MDT-modelThe 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 | Other | coordinated primary-care-based MDT-model |
| Standard Care (in control arm)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 |
Primary outcome
Ulcer healing
Time frame: Ulcer healing at 12 months
Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms
13 secondary outcomes
Time to ulcer healing
Time frame: 12 moths
Ulcer recurrence
Time frame: 12 months
Infections
Time frame: 12 months
Amputations
Time frame: 12 months
Visits
Time frame: 12 months
Hospital admissions
Time frame: 12 months
Patient related outcomes
Time frame: 12 months
Cost effectiveness
Time frame: 12 months
RE-AIM
Time frame: 12 months
RE-AIM
Time frame: 12 months
RE-AIM
Time frame: 12 months
RE-AIM
Time frame: 12 months
RE-AIM
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coordinated primary-care-based MDT-model in people with Diabetic Foot Disease and Diabetic Foot Infection, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Askø Andersen, Md Phd Clin Assoc Prof (+4548297451, jonas.hedegaard.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing (time frame: Ulcer healing at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.