The effect of zolendronic acid on the clinical resolution of acute midfoot Charcot foot

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000065998

Enrollment

Registered

2011-01-19

Start date

2002-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Diabetic Charcot foot is a rare but devastating foot complication of diabetes mellitus. The resolution of the acute form of Charcot foot needs immobilisation in a cast and total non-weight bearing for at least 12 to 16 weeks. Increased osteoclastic activity is thought to be one of the main pathological feature of the acute Charcot foot. That is why bisphosphonates are widely used in the treatment of acute Charcot process. There are some preliminary studies about the effect of bisphosphonates on the resolution of acute Charcot foot. In this study we investigated the effect of zoledronic acid on the clinical resolution of acute Charcot foot.

Interventions

Patients with acute Charcot foot receive either 3 intravenous infusions of placebo (normal saline) or 4mg of zolendronic acid (bisphosphonate) in 4 week intervals

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with acute unilateral Charcot foot and type I or type II diabetes mellitus

Exclusion criteria

Serum creatine >400 umol/l

Outcome results