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

Diabetic Foot Ulcer Clinical Trial

— FEENICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662831
• Other study ID #: A6301083
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Fragmin/ Dalteparin Sodium
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
• Placebo for Fragmin/ Dalteparin Sodium
Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Klagenfurt
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Ransart
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Czechia	Pfizer Investigational Site	Praha 4
Czechia	Pfizer Investigational Site	Praha 5
Czechia	Pfizer Investigational Site	Zlin
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Aarhus C
Denmark	Pfizer Investigational Site	Hvidovre
Denmark	Pfizer Investigational Site	Koebenhavn NV
Denmark	Pfizer Investigational Site	Odense C
Denmark	Pfizer Investigational Site	Soenderborg
Finland	Pfizer Investigational Site	Tampere
Germany	Pfizer Investigational Site	Karlsbad
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Melissia/Athens
Greece	Pfizer Investigational Site	Thessaloniki
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	San Giovanni Rotondo	FG
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Norway	Pfizer Investigational Site	Tonsberg
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Pulawy
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Spain	Pfizer Investigational Site	Getafe	Madrid
Spain	Pfizer Investigational Site	Girona
Spain	Pfizer Investigational Site	Madrid
Sweden	Pfizer Investigational Site	Karlstad
Sweden	Pfizer Investigational Site	Malmö
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lviv
Ukraine	Pfizer Investigational Site	Odessa
United Kingdom	Pfizer Investigational Site	Barnsley
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	Colchester
United Kingdom	Pfizer Investigational Site	Coventry
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Ipswich
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Peterborough

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Italy,  Lithuania,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of All Hemorrhages	Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.	Week 24 (EOT) or early termination
Other	Number of Major and Minor Hemorrhages	Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.	Week 24 (EOT) or early termination
Other	Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages	Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.	Week 24 (EOT) or early termination
Primary	Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing	University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.	Week 24 [end of treatment (EOT)] or early termination
Secondary	Number of Participants With Intact Skin Healing	Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.	Week 24 (EOT) or early termination
Secondary	Number of Participants Who Underwent Any Amputation	Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.	Week 24 (EOT) or early termination
Secondary	Number of Participants Who Underwent Major and Minor Amputation	A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.	Week 24 (EOT) or early termination
Secondary	Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing	University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.	Week 24 (EOT) or early termination
Secondary	Number of Participants Who Died		Week 24 (EOT) or early termination
Secondary	Number of Participants With Major Cardiovascular Disease Events (MCVE)	Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.	Week 24 (EOT) or early termination
Secondary	Time to Intact Skin Healing	Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.	Week 24 (EOT) or early termination
Secondary	Median Time to First Amputation		Week 24 (EOT) or early termination
Secondary	Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline and Week 24 (EOT or early termination)
Secondary	Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Baseline and Week 24 (EOT or early termination)
Secondary	36-Item Short-Form Health Survey (SF-36) Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline and Week 24 (EOT or early termination)
Secondary	11-point Likert Pain Scale	The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.	Baseline and Week 24 (EOT or early termination)
Secondary	Transcutaneous Local Tissue Oxygenation (pO2)	Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell.	Baseline and Week 24 (EOT or early termination)

External Links

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