Phase 3
N=276
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00662831 ↗Enrolled (actual)
276
Serious AEs
18.5%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing — 68; 31; 23; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fragmin/ Dalteparin Sodium (Drug); Placebo for Fragmin/ Dalteparin Sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing |
68; 31; 23; 14; 21; 10 | — |
| SECONDARY Number of Participants With Intact Skin Healing |
35; 16; 15; 4; 8; 4 | — |
| SECONDARY Number of Participants Who Underwent Any Amputation |
8; 2 | — |
| SECONDARY Number of Participants Who Underwent Major and Minor Amputation |
2; 1; 7; 1 | — |
| SECONDARY Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing |
33; 15; 8; 10; 13; 6 | — |
| SECONDARY Number of Participants Who Died |
4; 3 | — |
| SECONDARY Number of Participants With Major Cardiovascular Disease Events (MCVE) |
— | — |
| SECONDARY Time to Intact Skin Healing |
— | — |
| SECONDARY Median Time to First Amputation |
— | — |
| SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score |
0.60; 0.60; 0.70; 0.60 | — |
| SECONDARY Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) |
60.20; 55.30; 63.30; 60.70 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) Score |
34.70; 32.50; 35.40; 35.20; 42.30; 40.30 | — |
| SECONDARY 11-point Likert Pain Scale |
4.20; 4.50; 2.10; 2.50 | — |
| SECONDARY Transcutaneous Local Tissue Oxygenation (pO2) |
31.80; 36.00; 38.80; 39.70 | — |
Summary
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 18 years of age with type 1 or type 2 diabetes.
- Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of >3
Exclusion Criteria
- Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
- Subjects with a known bleeding disorder or evidence of active bleeding.
Data sourced from ClinicalTrials.gov (NCT00662831). 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.