Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (FEENICS)

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Foot Ulcer

Treatments: Drug: Fragmin/ Dalteparin Sodium; Drug: Placebo for Fragmin/ Dalteparin Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662831

A6301083

Details and patient eligibility

About

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.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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276 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Active study treatment

Treatment:

Drug: Fragmin/ Dalteparin Sodium

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo for Fragmin/ Dalteparin Sodium