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

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fragmin/ Dalteparin Sodium
Placebo for Fragmin/ Dalteparin Sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcers Neuroischaemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Active study treatment

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Number of Participants Who Died
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.
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.
Median Time to First Amputation
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.
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.
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).
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.
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.

Full Information

First Posted
April 16, 2008
Last Updated
November 29, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00662831
Brief Title
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic Foot Ulcers Neuroischaemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Active study treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Fragmin/ Dalteparin Sodium
Intervention Description
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
Intervention Type
Drug
Intervention Name(s)
Placebo for Fragmin/ Dalteparin Sodium
Intervention Description
Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.
Primary Outcome Measure Information:
Title
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing
Description
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.
Time Frame
Week 24 [end of treatment (EOT)] or early termination
Secondary Outcome Measure Information:
Title
Number of Participants With Intact Skin Healing
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Number of Participants Who Underwent Any Amputation
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Number of Participants Who Underwent Major and Minor Amputation
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Number of Participants Who Died
Time Frame
Week 24 (EOT) or early termination
Title
Number of Participants With Major Cardiovascular Disease Events (MCVE)
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Time to Intact Skin Healing
Description
Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Time Frame
Week 24 (EOT) or early termination
Title
Median Time to First Amputation
Time Frame
Week 24 (EOT) or early termination
Title
Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score
Description
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.
Time Frame
Baseline and Week 24 (EOT or early termination)
Title
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline and Week 24 (EOT or early termination)
Title
36-Item Short-Form Health Survey (SF-36) Score
Description
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).
Time Frame
Baseline and Week 24 (EOT or early termination)
Title
11-point Likert Pain Scale
Description
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.
Time Frame
Baseline and Week 24 (EOT or early termination)
Title
Transcutaneous Local Tissue Oxygenation (pO2)
Description
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.
Time Frame
Baseline and Week 24 (EOT or early termination)
Other Pre-specified Outcome Measures:
Title
Number of All Hemorrhages
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Number of Major and Minor Hemorrhages
Description
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.
Time Frame
Week 24 (EOT) or early termination
Title
Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages
Description
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.
Time Frame
Week 24 (EOT) or early termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Klagenfurt
ZIP/Postal Code
A-9020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Pfizer Investigational Site
City
Ransart
ZIP/Postal Code
6043
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Koebenhavn NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Soenderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Pfizer Investigational Site
City
Melissia/Athens
ZIP/Postal Code
15127
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Pfizer Investigational Site
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
49476
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
01102
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
10207
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Pfizer Investigational Site
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115998
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Pfizer Investigational Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M13 0JE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301083&StudyName=Study%20Of%20The%20Effect%20Of%20Fragmin%20In%20The%20Treatment%20Of%20Neuroischaemic%20Foot%20Ulcers%20In%20Diabetic%20Patients
Description
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Learn more about this trial

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

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