Phase 3
N=62
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00765063 ↗Enrolled (actual)
62
Serious AEs
17.7%
Results posted
Jan 2012
Primary outcome: Primary: Number of All Hemorrhages — 3 Hemorrhages
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fragmin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of All Hemorrhages |
3 | — |
| PRIMARY Number of Major Hemorrhages |
— | — |
| PRIMARY Number of Minor Hemorrhages |
3 | — |
| PRIMARY Number of Clinically Relevant Minor Hemorrhages |
2 | — |
| PRIMARY Number of Trivial Hemorrhages |
1 | — |
| SECONDARY Number of Participants With Intact Skin Healing |
19 | — |
| SECONDARY Number of Participants With Improved Ulcer Healing |
25 | — |
| SECONDARY Number of Participants Who Underwent Amputation |
1; 1; 0 | — |
| SECONDARY Time to Intact Skin Healing |
— | — |
| SECONDARY Time to First Amputation |
— | — |
| SECONDARY Number of Participants With Major Cardiovascular Disease Events (MCVE) |
— | — |
| SECONDARY 11-point Likert Pain Scale |
2.4; 2.2 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) Score |
34.7; 36.5; 45.1; 44.1; 48.1; 34.3 | — |
Summary
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.
Eligibility Criteria
Inclusion Criteria
- Subjects must have completed the 6 month study duration in the A6301083 study.
- Subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.
- All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system
Exclusion Criteria
- Subjects who have the following:
- Intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the EOT visit in the A6301083 study).
- A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ≥0%) in the A6301083 study.
- Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system.
- Subjects with a known bleeding disorder or evidence of active bleeding.
- Subjects who are on dialysis.
- Subjects who where found to be major protocol violators in A6301083 study.
- Subjects who did not complete the 6 month study period of the A6301083 study
Data sourced from ClinicalTrials.gov (NCT00765063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.