Completed

Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Prefabricated insoles

+ Custom made insoles 35 shore

+ 55 shore Custom made insole

Other
Who is being recruted

Cardiovascular Diseases+10

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2008
See protocol details

Summary

Principal SponsorSahlgrenska University Hospital
Last updated: July 29, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2008

Actual date on which the first participant was enrolled.

Patients included in the study were randomized into 3 different groups. Group number 1 and 2 got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55 shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. All patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. One and the same technician made the casting and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks after the first visit. At deliverance base line measurement was assessed.

NCT01663519
Principal SponsorSahlgrenska University Hospital
Last updated: July 29, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

114 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic NeuropathiesEndocrine System DiseasesLeg UlcerSkin DiseasesSkin UlcerVascular DiseasesFoot UlcerSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Foot

Criteria

5 inclusion criteria required to participate
Age > 18 year
Be able to read and understand Swedish
Be able to walk independently
Diabetes
Show More Criteria
1 exclusion criteria prevent from participating
Ulcers

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.

Group II

Experimental
Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate

Group III

Experimental
Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Lundbergs Laboratory for Orthopaedic Research

Gothenburg, SwedenOpen Lundbergs Laboratory for Orthopaedic Research in Google Maps
CompletedOne Study Center