## Protocol Section
### Identification Module
**NCT ID:** NCT01948479

**Brief Title:** Insole Optimisation for Ulcer Prevention: a Feasibility Trial

**Official Title:** Prevention of Foot Ulcer Recurrence in People With Diabetes Using an In-shoe Pressure Measurement Technology: A Randomised Control Trial Feasibility Study

#### Organization Study ID Info
**ID:** PatonRCT02
#### Organization
**Class:** OTHER
**Full Name:** University of Plymouth
### Status Module
#### Completion Date
**Date:** 2015-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2013-09-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-09-25

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-01

**Status Verified Date:** 2013-09

#### Study First Post Date
**Date:** 2013-09-23
**Type:** ESTIMATED
**Study First Submit Date:** 2013-09-18
**Study First Submit QC Date:** 2013-09-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University Hospital Plymouth NHS Trust

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Plymouth

#### Responsible Party

**Investigator Affiliation:** University of Plymouth

**Investigator Full Name:** Joanne Paton

**Investigator Title:** NIHR Clinical Research Fellow

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates.

Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration.

However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.

### Conditions Module

**Conditions:**

- Diabetic

- Neuropathic

- Past Ulceration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Optimised instant offloading insole

**Label:** Insole optimised with inshoe analysis

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Device: Optimised instant offloading insole

**Label:** Routine insole provision

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Insole optimised with inshoe analysis

- Routine insole provision

**Name:** Optimised instant offloading insole

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** ulcer recurrence rates

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** peak pressure reduction with the addition of the intervention

**Time Frame:** Issue and 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 30 years or above
* Diagnosed with Diabetes Mellitus
* Recently healed/healing target ulcer on the weight-bearing surface of the foot
* Neuropathic (Mild to moderate DPN defined as insensitivity of a 10 g monofilament at 1-3 sites in the following locations: hallux, 1st, 3rd, and 5th metatarsal heads (Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK: Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care 2008;31:1679-1685)
* Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

* The participant may not enter the study if ANY of the following apply: Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* None healing foot ulcer at another site that requires targeted off-loading.
* Unable to walk 5 metres with/without walking aid
* Peripheral vascular disease (non-re-constructible vascular disease as determined by arterial duplex and clinically assessed by a vascular consultant)
* Unwilling to wear therapeutic footwear
* Where amputation has been part of the current episode of care and includes ulceration site.

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** joanne.paton@plymouth.ac.uk

**Name:** Joanne Paton, PhD

**Phone:** 01752 588845

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Plymouth

**Contacts:**

***Contact 1:***

- **Email:** grahambruce1@nhs.net

- **Name:** Graham Bruce

- **Role:** CONTACT

***Contact 2:***

- **Name:** Graham Bruce

- **Role:** SUB_INVESTIGATOR

**Country:** United Kingdom

**Facility:** Derriford Hospital

**State:** Devon

**Zip:** PL6 8BH

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: HIGH

- As Found: Ulceration

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M18919

- Name: Foot Ulcer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014456

- Term: Ulcer

### Misc Info Module

- Version Holder: 2024-05-24
