Clinical trial NCT01259206: Plantar Faciitis and Diabetes Mellitus
Official title: Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Calcaneal Spur, Diabetic Obese Patients
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 93
Sex: ALL
Minimum age (years): 49
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 93 paitents and 42 control group

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).

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 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.

Primary outcomes:
measure: Increased Calcaneal Spur Incidence in Patients With Obesity and Type 2 Diabetes Mellitus
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Etlik
Study officials:
affiliation: No organizational affiliation
name: Aydoğan Aydoğdu
role: PRINCIPAL_INVESTIGATOR
References: