Plantar Faciitis and Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— No acronym  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259206
• Other study ID #: 11.10.2008/127
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: June 17, 2011
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: October 2008
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 49 Years to 69 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Etlik	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes