Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Plantar Faciitis and Diabetes Mellitus (No acronym)

This study has been completed.
Sponsor:
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01259206
First received: December 13, 2010
Last updated: June 17, 2011
Last verified: October 2008
  Purpose

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).


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Calcaneal spur incidence is increased in patients with diabetes mellitus.


Enrollment: 93
Study Start Date: February 2009
Study Completion Date: March 2009
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   49 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

93 paitents and 42 control group

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259206

Locations
Turkey
Gulhane School of Medicine Etlik
Ankara, Turkey, 06600
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
Principal Investigator: Aydoğan Aydoğdu No organizational affiliation
  More Information

No publications provided

Responsible Party: Gulhane School of Medicine, Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT01259206     History of Changes
Other Study ID Numbers: 11.10.2008/127
Study First Received: December 13, 2010
Last Updated: June 17, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Gulhane School of Medicine:
Calcaneal Spur, Diabetic Obese Patients

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014