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Insole Optimisation for Ulcer Prevention: a Feasibility Trial

Primary Purpose

Diabetic, Neuropathic, Past Ulceration

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Optimised instant offloading insole

About this trial

This is an interventional prevention trial for Diabetic

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insole optimised with inshoe analysis

Routine insole provision

Arm Description

Outcomes

Primary Outcome Measures

ulcer recurrence rates

Secondary Outcome Measures

peak pressure reduction with the addition of the intervention

Full Information

NCT ID

NCT01948479

First Posted

September 18, 2013

Last Updated

September 25, 2013

Sponsor

University of Plymouth

Collaborators

University Hospital Plymouth NHS Trust

1. Study Identification

Unique Protocol Identification Number

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2015 (Anticipated)

Study Completion Date

January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Plymouth

Collaborators

University Hospital Plymouth NHS Trust

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic, Neuropathic, Past Ulceration

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Insole optimised with inshoe analysis

Arm Type

Experimental

Arm Title

Routine insole provision

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Optimised instant offloading insole

Primary Outcome Measure Information:

Title

ulcer recurrence rates

Time Frame

6 months

Secondary Outcome Measure Information:

Title

peak pressure reduction with the addition of the intervention

Time Frame

Issue and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joanne Paton, PhD

Phone

01752 588845

joanne.paton@plymouth.ac.uk

Facility Information:

Facility Name

Derriford Hospital

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8BH

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Graham Bruce

grahambruce1@nhs.net

First Name & Middle Initial & Last Name & Degree

Graham Bruce

12. IPD Sharing Statement

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Insole Optimisation for Ulcer Prevention: a Feasibility Trial

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