Intranasal calcitonin in the treatment of acute Charcot neuroosteoarthropathy: a randomized controlled trial
| ISRCTN | ISRCTN91576704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91576704 |
| Secondary identifying numbers | MZO00023001 |
- Submission date
- 02/01/2006
- Registration date
- 13/01/2006
- Last edited
- 18/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Bem
Scientific
Scientific
Videnska 1958/9
Prague 4
14021
Czech Republic
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | Intranasal calcitonin can be effective in the treatment of acute Charcot foot. |
| Ethics approval(s) | The study was approved by the local ethics committee, and all participants gave written informed consent. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Calcitonin, calcium |
| Primary outcome measure | 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 study start date | 01/08/2003 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Acute Charcot foot 2. Type 1 or Type 2 Diabetes |
| Key exclusion criteria | 1. Foot ulcer 2. Acute osteomyelitis |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Videnska 1958/9
Prague 4
14021
Czech Republic
14021
Czech Republic
Sponsor information
Institute for Clinical and Experimental Medicine (Czech Republic)
Industry
Industry
Videnska 1958/9
Prague 4
14021
Czech Republic
| Website | http://www.ikem.cz |
|---|---|
"ROR" |
https://ror.org/036zr1b90 |
Funders
Funder type
Research organisation
Institute for Clinical and Experimental Medicine MZO00023001 (Czech Republic)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
