Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/01/2006
Date assigned
13/01/2006
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Bem

ORCID ID

Contact details

Videnska 1958/9
Prague 4
14021
Czech Republic

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MZO00023001

Study information

Scientific title

Acronym

Study hypothesis

Intranasal calcitonin can be effective in the treatment of acute Charcot foot.

Ethics approval

The study was approved by the local ethics committee, and all participants gave written informed consent.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Diabetic Foot

Intervention

Intranasal Calcitonin 200 IU + Calcium 1000 mg per day or Calcium 1000 mg per day in monotherapy; two years follow-up period.

Intervention type

Drug

Phase

Not Specified

Drug names

Calcitonin, calcium

Primary outcome measures

1. Effect on bone remodeling markers
2. Markers of disease activity - skin temperature

Secondary outcome measures

1. Prevention of deformities
2. Shortening of the treatment
3. Recurrence of Charcot foot

Overall trial start date

01/08/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute Charcot foot
2. Type 1 or Type 2 Diabetes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Foot ulcer
2. Acute osteomyelitis

Recruitment start date

01/08/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Videnska 1958/9
Prague 4
14021
Czech Republic

Sponsor information

Organisation

Institute for Clinical and Experimental Medicine (Czech Republic)

Sponsor details

Videnska 1958/9
Prague 4
14021
Czech Republic

Sponsor type

Industry

Website

http://www.ikem.cz

Funders

Funder type

Research organisation

Funder name

Institute for Clinical and Experimental Medicine MZO00023001 (Czech Republic)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes