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Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes

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ClinicalTrials.gov Identifier: NCT02061059
Recruitment Status : Unknown
Verified February 2014 by Maastricht University.
Recruitment status was:  Not yet recruiting
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Maastricht University

Brief Summary:
The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Polyneuropathies Other: block 1 Other: block 2 Other: standard Other: with measurements Not Applicable

Detailed Description:
For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
Study Start Date : March 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
group 1

group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements.

group is assigned to "standard": wears shoes produced with standard procedure

Other: block 1
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements

Other: standard
patient wears shoes produced with standard method

group 2

group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements

group is assigned to "with measurements": wears shoes produced with plantar pressure measurements

Other: block 1
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements

Other: with measurements
patient wears shoes produced with plantar pressure measurements

group 3

group is assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

group is assigned to "standard": wears shoes produced with standard procedure

Other: block 2
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

Other: standard
patient wears shoes produced with standard method

group 4

group assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

group is assigned to "with measurements": wears shoes produced with plantar pressure measurements

Other: block 2
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

Other: with measurements
patient wears shoes produced with plantar pressure measurements




Primary Outcome Measures :
  1. The cost-effectiveness of shoes produced with and without plantar pressure measurements. [ Time Frame: approximately 10 weeks (at delivery of the shoes) ]

Secondary Outcome Measures :
  1. Change in plantar pressure after wearing the therapeutic shoes for 3 months. [ Time Frame: approximately 22 weeks (at follow-up) ]
  2. The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions. [ Time Frame: approximately 22 weeks (at follow-up) ]
    The number of diabetic foot problems serves as an additional measure of the quality of the therapeutic shoes produced.

  3. Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes. [ Time Frame: approximately 10 weeks (at delivery of the shoes) ]
    Qualitative measure of differences in production process of the shoes produced with or without plantar pressure measurements.

  4. Differences in plantar pressures between the two shoes produced. [ Time Frame: approximately 10 weeks (at delivery of the shoes) ]
  5. The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes". [ Time Frame: approximately 22 weeks (at follow-up) ]
  6. Differences in plantar pressures between the two shoes produced. [ Time Frame: approximately 22 weeks (at follow-up) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes
  • neuropathy
  • prescription of therapeutic footwear
  • diabetic foot ulcer in the last 5 years
  • receiving regular preventive foot care
  • written informed consent

Exclusion Criteria:

  • peripheral arterial disease
  • not motivated to wear therapeutic footwear
  • active foot ulcer
  • recent vascular intervention
  • severe mobility impairment
  • amputation more proximal than toes, except a single ray amputation is allowed.
  • severe visual impairment
  • active cancer
  • severe cardiac/ pulmonary failure
  • severe oedema
  • chronic drug abuse
  • severe psychiatric illness
  • hospital admission at the time of inclusion
  • any condition that may interfere with follow-up visits.

Information from the National Library of Medicine

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): NCT02061059


Contacts
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Contact: Tom Melai, PhD +31 43 3881398 tom.melai@MaastrichtUniversity.nl

Locations
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Netherlands
Maastricht University Not yet recruiting
Maastricht, Netherlands, 6200MD
Sub-Investigator: Tom Melai, PhD         
Smeets Loopcomfort Not yet recruiting
Sittard, Netherlands, 6135 LE
Sub-Investigator: Tom Melai, PhD         
Sponsors and Collaborators
Maastricht University
Investigators
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Principal Investigator: Nicolaas C Schaper, PhD, MD Maastricht University Medical Center
Study Director: Hans H Savelberg, PhD Maastricht University

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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT02061059     History of Changes
Other Study ID Numbers: 13-1-112.3
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Polyneuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases