Plantar Faciitis and Diabetes Mellitus (No acronym)

June 17, 2011 updated by: Gulhane School of Medicine

Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus

Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).

Study Overview

Status

Completed

Conditions

Detailed Description

OBJECTIVE-Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS-Ninety-three obese patients with T2DM and forty-two obese subjects without any metabolic disturbances as control were evaluated with lateral calcaneal x-ray in blinded fashion by a radiologist. All participants were informed and written consents have been obtained. Control cases were subjected to 75g glucose challenge test and glucose intolerant subjects were excluded.

RESULTS-T2DM and control groups were statistically similar in mean age (59±10.5 vs. 55±8 yrs, P=0.196, respectively) and mean body mass index (BMI)(35.1±4.3 vs. 33.1±3.3 kg/m2, P=0.073, respectively). Existence of calcaneal spur was 72% in 93 patients (77%) in T2DM group and 24 in 42 (57%) in control group. Groups were significantly different according to existence of CS (P=0.023). Mean age and mean BMI were significantly higher in diabetic patients with calcaneal spur than diabetic patients without calcaneal spur (p=0.001 and p=0.015, respectively). There was positive correlation between existence of calcaneal spur and peripheral neuropathy (p=0,043) in diabetics but no significant relation between existence of CS and glycolysed hemoglobin levels or diabetes duration (all P>0.05).

CONCLUSIONS-Clinicians should pay attention the increased incidence of CS in patients with T2DM to avoid foot complications.

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06600
        • Gulhane School of Medicine Etlik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

93 paitents and 42 control group

Description

Inclusion Criteria:

  • Clinical diagnosis of Diabetes mellitus
  • Must be obese

Exclusion Criteria:

  • Previous radiotherapy to the foot,
  • previous trauma to the foot (fracture, rupture of tendon),
  • rheumatic or vascular diseases,
  • malign diseases,
  • lymphatic edema.

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
diabetic patients
diabetic patients and healty controls
there are two groups in this study. One group is obese type 2 diabetic patiens and other group is healty controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
Time Frame: 3 months
Calcaneal spur incidence is increased in patients with diabetes mellitus.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Investigators

  • Principal Investigator: Aydoğan Aydoğdu, No organizational affiliation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.10.2008/127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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