Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Ulcer (DFU), Hard to Heal Wounds, Ulcer
Conditions
Keywords
Diabetic Foot Ulcer, MDT, Hard-to-heal ulcer, Cross Sectional Collaboration
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.
Interventions
OTHERcoordinated primary-care-based MDT-model
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
OTHERStandard 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.
Sponsors
Nordsjaellands Hospital
Frederikssund Municipality, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing | Ulcer healing at 12 months | Number of individuals that achieve healing of their hard-to-heal ulcer(s), compared between two arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ulcer healing | 12 moths | Mean time (in days) to healing of healed hard-to-heal ulcer(s) in days - compared between groups |
| Ulcer recurrence | 12 months | Incidence of recurrence of ulcer following healing of hard-to-heal ulcer(s) - compared between groups |
| Infections | 12 months | Incidence of infections divided in * Infection treated with tablet antibiotic * Infection treated with intravenous antibiotics, admittance to hospital and/or surgery Compared between groups |
| Amputations | 12 months | Incidence and amputations in total and divided in * Below ankle amputation * Above ankle amputations Compared between groups |
| Visits | 12 months | Number of visits to clinics due to hard-to-heal ulcer(s) - compared between groups |
| Hospital admissions | 12 months | Days admitted to hospital due to hard-to-heal ulcer(s) - compared between groups |
| Patient related outcomes | 12 months | 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. |
| Cost effectiveness | 12 months | 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 |
| RE-AIM | 12 months | 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. |
Countries
Denmark
Contacts
CONTACTJonas Askø Andersen, Md Phd Clin Assoc Prof
Outcome results
None listed