Status:
COMPLETED
A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration
Lead Sponsor:
University of Plymouth
Collaborating Sponsors:
Cornwall and Illes of Scilly Primary Care Trust
Plymouth Teaching Primary Care Trust
Conditions:
Diabetes
Neuropathic Foot
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
Importance of the topic: Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented....
Detailed Description
Aim The study compared custom-made functional insoles with prefabricated insoles for the preventative management of neuropathic diabetic feet, assessing effects on peak pressure, forefoot pressure tim...
Eligibility Criteria
Inclusion
- diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant),
- diagnosed with diabetic peripheral neuropathy
- palpable or biphasic pulses
- intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer
- able to walk a minimum of 10 metres unaided
- willing to comply with the requirements of the study.
Exclusion
- presented with current or recently healed ulceration less than 6 months prior to study enrolment,
- severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non- bespoke footwear,
- history of major bone or joint surgery of the lower limb including major amputation
- unable to comprehend simple instructions and comply with the study protocols and procedures.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00999635
Start Date
March 1 2006
End Date
September 1 2008
Last Update
October 27 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Liskeard Community Hospital
Liskeard, Cornwall, United Kingdom
2
Local Care Center Mount Gould
Plymouth, Devon, United Kingdom