NCT01259206

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
Last Updated

June 21, 2011

Status Verified

October 1, 2008

First QC Date

December 13, 2010

Last Update Submit

June 17, 2011

Conditions

Diabetes Mellitus

Keywords

Calcaneal Spur, Diabetic Obese Patients

Outcome Measures

Primary Outcomes (1)

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

    Calcaneal spur incidence is increased in patients with diabetes mellitus.

    3 months

Study Arms (2)

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.

Eligibility Criteria

Age49 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

93 paitents and 42 control group

You may qualify if:

  • Clinical diagnosis of Diabetes mellitus
  • Must be obese

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Etlik

Ankara, 06600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusHeel Spur

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesExostosesHyperostosisBone DiseasesMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Aydoğan Aydoğdu

    No organizational affiliation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 14, 2010

Study Start

February 1, 2009

Study Completion

March 1, 2009

Last Updated

June 21, 2011

Record last verified: 2008-10

Locations

TU(1)