You are here

Our science / Clinical Trials / Find a Trial / NCT00662831

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

Back to Search Print Save as PDF Bookmark Trial

NCT00662831

Last updated on October 4, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Klagenfurt, , A-9020 Austria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Foot Ulcer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00662831
Pfizer
Completed
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Ulcerative Colitis
A Clinical Study of PF-06480605 for the Treatment of Moderate to Severe Ulcerative Colitis. (TUSCANY, B7541002)
NCT02840721
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis
Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis
NCT03414788
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis
PF-06687234 add on therapy in active UC subjects - BUILD UC
NCT03269695
All Genders
18+
Years
Multiple Sites
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease
Post-Marketing Use Of Inflectra (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
NCT02539368
All Genders
18+
Years
Multiple Sites
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
A 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • Drug: Fragmin/ Dalteparin Sodium
    Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
  • Drug: Placebo for Fragmin/ Dalteparin Sodium
    Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.
  • Experimental: Active
    Active study treatment
    Intervention: Drug: Fragmin/ Dalteparin Sodium
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo for Fragmin/ Dalteparin Sodium
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Italy,   Lithuania,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom
France,   Netherlands
 
NCT00662831
A6301083
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now