Plantar Faciitis and Diabetes Mellitus

NCT ID: NCT01259206

Last Updated: 2011-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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diabetic patients

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

49 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gulhane School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Department of Endocrinology and Metabolism

Principal Investigators

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Aydoğan Aydoğdu

Role: PRINCIPAL_INVESTIGATOR

No organizational affiliation

Locations

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Gulhane School of Medicine Etlik

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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11.10.2008/127

Identifier Type: -

Identifier Source: org_study_id

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