Induce (Intellin Diabetic Foot) Feasibility Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03591081 |
Recruitment Status :
Completed
First Posted : July 18, 2018
Last Update Posted : August 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Healed Ulcer | Other: Intellin smart phone application | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Feasibility Study to Explore the Implementation and Acceptance of INTELLIN, a Novel mHealth Application on the Management of People With Diabetes Who Have Recently Healed Foot Ulceration. |
Actual Study Start Date : | June 22, 2018 |
Actual Primary Completion Date : | March 20, 2020 |
Actual Study Completion Date : | March 20, 2020 |

Arm | Intervention/treatment |
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Intellin smart phone application
Participants will download a smart phone app, the platform will give the patients daily hints and tips on how to look after their feet.
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Other: Intellin smart phone application
This feasibility study will explore if creating an electronic platform Intellin smart phone application can promote and support timely self-referral for individuals with a recently healed DFU. It will explore the software applications acceptance and ease of use for patients. |
- 1 Acceptability, suitability and usability of the INTELLIN platform [ Time Frame: 12 months ]A 5-point rating scale as assessed by the participants and the clinical team. The 5 point rating is a likert scale where respondants are offered a choice of 5 pre coded responses 1 being strongly disagree 2 disagree 3 (neutral point) niether disagree or agree 4 agree and 5 strongly agree so the individual can express how much they agree or disagree with the experience of using the application
- The proportion of patients who self-refer for recurrence of diabetic foot-ulcer over a twelve-month period, compared with the current National diabetes foot audit average of 33.3% [ Time Frame: 12 months ]Proportion of participants self-referring using the Intellin platform SOS button over 12 months compared with the current National diabetes foot audit average of 33.3%
- Proportion of patients who would recommend Intellin platform to others [ Time Frame: 12 months ]A 5-point rating scale as assessed by the participants and the clinical team A 5-point rating scale as assessed by the participants and the clinical team. The 5 point rating is a likert scale where respondants are offered a choice of 5 pre coded responses 1 being strongly disagree 2 disagree 3 (neutral point) niether disagree or agree 4 agree and 5 strongly agree so the individual can express how much they agree or disagree with the experience of using the application.
- Proportion of patients who access the Intellin app every day [ Time Frame: 12 months ]Case report form and the app electronic database
- Proportion of patients who discontinue the study because they are unable to use the app [ Time Frame: 12 months ]Case report form
- The proportion of patients who report that the INTELLIN app has improved their understanding of the need for the 8 annual checks [ Time Frame: 12 months ]Case report form and the app electronic database
- The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes [ Time Frame: 12 months ]Case report form and the app electronic database
- Proportion of patients completing NICE 8 point annual checks over 12 months compared with the current national diabetes foot audit average of 60% [ Time Frame: 12 months ]Case report form and the app electronic database
- Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines [ Time Frame: 12 months ]Case report form
- Time to recurrence of ulcer over 12 months. [ Time Frame: 12 months ]Data will be compared to published rates
- The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers [ Time Frame: 12 months ]Drivers of cost utilisation to include, number of GP visits, outpatient visits, hospital bed medication and type of medication, procedures for patients that develop an ulcer
- The effect of using INTELLIN on quality of life [ Time Frame: 12 months ]EQ-5D-5L questionnaire
- The proportion of patients with recurrence of foot ulcer over 12 months [ Time Frame: 12 months ]As compared to published data
- The proportion of patients with lower limb amputations [ Time Frame: 12 months ]As compared to published data
- Changes in cardiovascular markers [ Time Frame: 12 months ]Blood pressure measurements, blood test results and medication

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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• 18 years of age will be screened to meet the eligibility criteria:
- Consultant or GP diagnosis of diabetes mellitus (Type I or II) , documented on the electronic patient record with HbA1C greater than 48mmol/mol
- History of a recent diabetes foot ulcer defined as being eligible for the national diabetes foot audit and classified as healed for at least 4 weeks and no more than 12 weeks
- Able to provide informed consent
- Has no reasons that they could not be part of the study for 12 months such as moving out the area for attending appointments or short life expectancy from a diagnosed illness
- Owns a smart phone
Exclusion Criteria:
- No smart phone
- Comorbidity such as poor eyesight which limits the use of smart phone
- Participation in an interventional study within the last 30 days
- Critical illness that prevents participating for a period of time

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591081
United Kingdom | |
Podiatry Department Salford Royal NHS Foundation Trust | |
Salford, United Kingdom, M6 8HD |
Principal Investigator: | Joanne McCardle | Northern Care Alliance NHS Foundation Trust |
Responsible Party: | Natalie Garratt, Research & Development Lead, Northern Care Alliance NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT03591081 |
Other Study ID Numbers: |
S18DIAB04-S |
First Posted: | July 18, 2018 Key Record Dates |
Last Update Posted: | August 20, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetic foot |
Diabetes Complications Diabetes Mellitus Diabetic Foot Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases |
Foot Ulcer Leg Ulcer Skin Ulcer Skin Diseases Endocrine System Diseases Diabetic Neuropathies |