Leg UlcerSNAKNCT06255288
Time to Heal (Wound, Healing, Dialogue, Nutrition)
A study testing SNAK intervention in people with Leg Ulcer and Venous Leg Ulcer, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer, Venous Leg Ulcer, Arterial Leg Ulcer
- What is being tested?
- SNAK intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jan 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with leg ulcers caused by arterial or venous disease or neuropathy caused by diabetes.
- Patient with an amputation wound.
- Speak and understand Danish.
Who cannot join
- Patients with wounds caused by high-intensity trauma.
- Patients in the end-of-life phase.
- Patients living in nursing homes.
- Patients with cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital
Copenhagen, 2650
About this study
Official title: A Nurse-led Intervention Consisting of a Structured Dialogue, Patient and Relative Information, and Protein Supplement for Patients with Leg Ulcers in Clinical Practice: a Feasibility Study
The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.
Read the detailed description
The study aims to address the following research questions:
Primary Research Questions:
- Is the patient recruitment process feasible?
- Is the delivery of the intervention feasible?
- Is the intervention acceptable to the patients?
- Is the intervention acceptable to the nurses?
- Is the intervention consistently maintained during the study period?
- Are the data collection procedures feasible?
- Are the outcome measures feasible?
- What are the reasons for any dropouts?
Secondary Research Questions:
- What are the patients' and relatives' views on receiving the intervention?
- Are there any longitudinal differences in outcomes for the patient group?
- Are there any individual patient-specific differences in outcomes over time?
The feasibility study will recruit patients with a first-time referral to the outpatient clinic at the Department of Orthopaedic Surgery at Copenhagen University Hospital, Hvidovre, for leg ulcers caused by arterial or venous disease or neuropathy due to diabetes. The intervention will be administered by the clinic's nurses.
After inclusion, each patient will be contacted by telephone following their next two clinic visits. The initial follow-up will assess patient characteristics, information about their wound using the Wound-Qol Questionnaire, and their perspective on receiving the intervention. The second and final follow-up will consist of an interview exploring their perspective on receiving the intervention. Additionally, focus group interviews with the nurses will be conducted to investigate their capability, opportunity, and motivation (COM-B model) for implementing the intervention. Both patient and nurse interviews will be recorded and transcribed.
- Being tested
- SNAK intervention
- Keywords
- Leg ulcer, Nutrition, Dialogue, Diet, Nursing
- Medical subject headings
- Leg Ulcer, Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAK interventionOther
The intervention consists of structured dialogue, patient information, and a protein supplement. The structured dialogue part of the intervention consists of an A3 poster with illustrations and keywords which will be hanging in the outpatient clinics. The poster will be utilized by nurses, patients, and their relatives to facilitate a dialogue regarding nutrition and wound healing. The patient information part of the intervention consists of a leaflet with easy-to-read information, which patients and their relatives can bring home after their visit to the outpatient clinic. The leaflet will consist of general information as well as food categories and recipes they can use to enhance their daily protein intake. For the protein supplement part of the intervention, the patients will have access to protein supplement beverages while they are in the outpatient clinic waiting room. Furthermore, they will receive prescriptions for protein drinks, that they can pick up at their local pharmacy.
| Study group | Role | What they receive |
|---|---|---|
| Dialogue, patient information and protein supplement | Experimental | Patient will receive:
1. Structured nutritional dialogue during two visits to the clinic.
2. Written patient information (pamphlet) during their first visit to the clinic.
3. Protein supplement drink during two visits to the clinic.
4. Prescription of protein supplement drink during their first visit to the clinic. Receives: Other: SNAK intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue
The intervention is deemed non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients:
- Noticed the dialogue tool.
- Had a conversation with the nurses about nutrition and wound healing using the dialogue tool.
- Found the conversation with the nurses about nutrition and wound healing relevant and valuable.
- Considered it acceptable to have a conversation with the nurses about nutrition and wound healing.
The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
Measured: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
SNAK Feasibility questionnaire (SFQ) - Element 2: Evaluating patient and relative information
The intervention is considered non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients:
- Received a leaflet.
- Could read and understand the leaflet.
- Found the information in the leaflet relevant.
- have attempted to use the suggested recipes or food categories.
- have attempted to change their diet.
The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
Measured: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement
The intervention is considered non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients:
- Were offered a protein supplement drink.
- Were offered a prescription for protein supplement drinks.
- Agree that patients should be offered a protein supplement drink.
The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
Measured: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
SNAK Feasibility questionnaire (SFQ) - Element 4: Evaluating overall intervention
The intervention is considered non-feasible if fewer than 80% of the patients, during their visit to the outpatient clinic, are confident that they can follow the advice regarding nutrition and lifestyle in their daily lives.
The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
Measured: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
Qualitative evaluation of nurses' Capability, Opportunity, and Motivation (COM-B) to implement the intervention.
COM-B will be explored using a semi-structured focus group interview with the nurses and will be carried out in the outpatient clinic following the end of inclusion (16 weeks after first inclusion).
Measured: Measured 16 weeks after first inclusion.
Procedural uncertainties - Number of patients willing to participate.
Following criteria are considered to evaluate the recruitment of participation in the intervention.
- If less than 30% are willing to participate in the intervention, then the intervention is considered non-feasible.
- If recruitment falls within the range of 30 to 80% modification will be considered.
If 80% or more are recruited, the study is deemed feasible without modification.
Measured: Measured 4, 8, 12, and 16 weeks after first inclusion.
Secondary outcomes (2)
Recruitment rates
The number of eligible patients that agree to participate will be collected.
Measured: Every week until study completion (16 weeks after first inclusion).
Drop out rates
The number of included patients that withdraw consent or drop out for other reasons will be collected. Furthermore, we will collect reasons for dropout.
Measured: Every week until study completion (16 weeks after first inclusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start23 Jan 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roskilde University
- Responsible party
- Principal investigator, Pia Søe Jensen, Hvidovre University Hospital
- Investigators
- Pia Søe Jensen, Principal investigator, Hvidovre University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255288
- Sponsor's protocol ID
- F-23054461
- Acronym
- SNAK
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led Intervention Consisting of a Structured Dialogue, Patient and Relative Information, and Protein Supplement for Patients with Leg Ulcers in Clinical Practice: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06255288
- Acronym / sponsor ID
- SNAK / F-23054461
- Keywords
- Leg ulcer, Nutrition, Dialogue, Diet, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Roskilde University
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 13 Feb 2024 (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 objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.
Detailed description
The study aims to address the following research questions:
Primary Research Questions:
- Is the patient recruitment process feasible?
- Is the delivery of the intervention feasible?
- Is the intervention acceptable to the patients?
- Is the intervention acceptable to the nurses?
- Is the intervention consistently maintained during the study period?
- Are the data collection procedures feasible?
- Are the outcome measures feasible?
- What are the reasons for any dropouts?
Secondary Research Questions:
- What are the patients' and relatives' views on receiving the intervention?
- Are there any longitudinal differences in outcomes for the patient group?
- Are there any individual patient-specific differences in outcomes over time?
The feasibility study will recruit patients with a first-time referral to the outpatient clinic at the Department of Orthopaedic Surgery at Copenhagen University Hospital, Hvidovre, for leg ulcers caused by arterial or venous disease or neuropathy due to diabetes. The intervention will be administered by the clinic's nurses.
After inclusion, each patient will be contacted by telephone following their next two clinic visits. The initial follow-up will assess patient characteristics, information about their wound using the Wound-Qol Questionnaire, and their perspective on receiving the intervention. The second and final follow-up will consist of an interview exploring their perspective on receiving the intervention. Additionally, focus group interviews with the nurses will be conducted to investigate their capability, opportunity, and motivation (COM-B model) for implementing the intervention. Both patient and nurse interviews will be recorded and transcribed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialogue, patient information and protein supplement | Experimental | Other: SNAK interventionPatient will receive: 1. Structured nutritional dialogue during two visits to the clinic. 2. Written patient information (pamphlet) during their first visit to the clinic. 3. Protein supplement drink during two visits to the clinic. 4. Prescription of protein supplement drink during their first visit to the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with leg ulcers caused by arterial or venous disease or neuropathy caused by diabetes.
- Patient with an amputation wound.
- Speak and understand Danish.
Key exclusion criteria (4 listed)
- Patients with wounds caused by high-intensity trauma.
- Patients in the end-of-life phase.
- Patients living in nursing homes.
- Patients with cognitive impairment.
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 |
|---|---|---|
| SNAK interventionThe intervention consists of structured dialogue, patient information, and a protein supplement. The structured dialogue part of the intervention consists of an A3 poster with illustrations and keywords which will be hanging in the outpatient clinics. The poster will be utilized by nurses, patients, and their relatives to facilitate a dialogue regarding nutrition and wound healing. The patient information part of the intervention consists of a leaflet with easy-to-read information, which patients and their relatives can bring home after their visit to the outpatient clinic. The leaflet will consist of general information as well as food categories and recipes they can use to enhance their daily protein intake. For the protein supplement part of the intervention, the patients will have access to protein supplement beverages while they are in the outpatient clinic waiting room. Furthermore, they will receive prescriptions for protein drinks, that they can pick up at their local pharmacy. | Other | Dialogue, patient information and protein supplement |
Primary outcome
SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue
Time frame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
The intervention is deemed non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients: 1. Noticed the dialogue tool. 2. Had a conversation with the nurses about nutrition and wound healing using the dialogue tool. 3. Found the conversation with the nurses about nutrition and wound healing relevant and valuable. 4. Considered it acceptable to have a conversation with the nurses about nutrition and wound healing. The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
SNAK Feasibility questionnaire (SFQ) - Element 2: Evaluating patient and relative information
Time frame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
The intervention is considered non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients: 1. Received a leaflet. 2. Could read and understand the leaflet. 3. Found the information in the leaflet relevant. 4. have attempted to use the suggested recipes or food categories. 5. have attempted to change their diet. The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement
Time frame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
The intervention is considered non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients: 1. Were offered a protein supplement drink. 2. Were offered a prescription for protein supplement drinks. 3. Agree that patients should be offered a protein supplement drink. The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
SNAK Feasibility questionnaire (SFQ) - Element 4: Evaluating overall intervention
Time frame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
The intervention is considered non-feasible if fewer than 80% of the patients, during their visit to the outpatient clinic, are confident that they can follow the advice regarding nutrition and lifestyle in their daily lives. The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
Qualitative evaluation of nurses' Capability, Opportunity, and Motivation (COM-B) to implement the intervention.
Time frame: Measured 16 weeks after first inclusion.
COM-B will be explored using a semi-structured focus group interview with the nurses and will be carried out in the outpatient clinic following the end of inclusion (16 weeks after first inclusion).
Procedural uncertainties - Number of patients willing to participate.
Time frame: Measured 4, 8, 12, and 16 weeks after first inclusion.
Following criteria are considered to evaluate the recruitment of participation in the intervention. 1. If less than 30% are willing to participate in the intervention, then the intervention is considered non-feasible. 2. If recruitment falls within the range of 30 to 80% modification will be considered. If 80% or more are recruited, the study is deemed feasible without modification.
2 secondary outcomes
Recruitment rates
Time frame: Every week until study completion (16 weeks after first inclusion).
Drop out rates
Time frame: Every week until study completion (16 weeks after first inclusion).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pia Søe Jensen principal investigator
Hvidovre University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAK intervention in people with Leg Ulcer and Venous Leg Ulcer, run by Hvidovre University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue (time frame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.). The study lists 6 primary outcomes in all. 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 19 Feb 2025.