Insole Optimisation for Ulcer Prevention: a Feasibility Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University of Plymouth
Sponsor:
Collaborator:
Plymouth Hospitals NHS Trust
Information provided by (Responsible Party):
Joanne Paton, University of Plymouth
ClinicalTrials.gov Identifier:
NCT01948479
First received: September 18, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Diabetic
Neuropathic
Past Ulceration
Device: Optimised instant offloading insole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Foot Ulcer Recurrence in People With Diabetes Using an In-shoe Pressure Measurement Technology: A Randomised Control Trial Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Plymouth:

Primary Outcome Measures:
  • ulcer recurrence rates [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • peak pressure reduction with the addition of the intervention [ Time Frame: Issue and 6 months ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insole optimised with inshoe analysis Device: Optimised instant offloading insole
Active Comparator: Routine insole provision Device: Optimised instant offloading insole

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948479

Contacts
Contact: Joanne Paton, PhD 01752 588845 joanne.paton@plymouth.ac.uk

Locations
United Kingdom
Derriford Hospital Not yet recruiting
Plymouth, Devon, United Kingdom, PL6 8BH
Contact: Graham Bruce       grahambruce1@nhs.net   
Sub-Investigator: Graham Bruce         
Sponsors and Collaborators
University of Plymouth
Plymouth Hospitals NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Joanne Paton, NIHR Clinical Research Fellow, University of Plymouth
ClinicalTrials.gov Identifier: NCT01948479     History of Changes
Other Study ID Numbers: PatonRCT02
Study First Received: September 18, 2013
Last Updated: September 25, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014