The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00765063
• Collaborator: (none)
• Enrollment: 62
• Locations: 27
• Arm: 1
• Duration (Months): 24
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Drug: Fragmin	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 6 Month, Prospective, Open-Label Multiple Center Extension Trial To Evaluate The Long Term Safety And Sustained Efficacy Of Fragmin In The Treatment Of Chronic Foot Ulcers In Diabetic Patients With Peripheral Arterial Occlusive Disease
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Active study treatment	Drug: Fragmin; Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium; Other Names: Dalteparin sodium

Outcome Measures

Primary Outcome Measures

1. Number of All Hemorrhages [Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)]

   Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater 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.

2. Number of Major Hemorrhages [Baseline to Week 24 (EOT) or ET]

   Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater 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).

3. Number of Minor Hemorrhages [Baseline to Week 24 (EOT) or ET]

   Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

4. Number of Clinically Relevant Minor Hemorrhages [Baseline to Week 24 (EOT) or ET]

   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.

5. Number of Trivial Hemorrhages [Baseline to Week 24 (EOT) or ET]

   Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

Secondary Outcome Measures

1. Number of Participants With Intact Skin Healing [Baseline through Week 24 (EOT) or ET]

   Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.

2. Number of Participants With Improved Ulcer Healing [Baseline through Week 24 (EOT) or ET]

   Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.

3. Number of Participants Who Underwent Amputation [Baseline through Week 24 (EOT) or ET]

   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.

4. Time to Intact Skin Healing [Baseline through Week 24 (EOT) or ET]

   Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.

5. Time to First Amputation [Baseline through Week 24 (EOT) or ET]

6. Number of Participants With Major Cardiovascular Disease Events (MCVE) [Baseline through Week 24 (EOT) or ET]

   MCVE 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.

7. 11-point Likert Pain Scale [Baseline and Week 24 (EOT) or ET]

   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.

8. 36-Item Short-Form Health Survey (SF-36) Score [Baseline and Week 24 (EOT) or ET]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have completed the 6 month study duration in the A6301083 study.

• Subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.

• All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system

Exclusion Criteria:

• Subjects who have the following:

• Intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the EOT visit in the A6301083 study).

• A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ≥0%) in the A6301083 study.

• Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system.

• Subjects with a known bleeding disorder or evidence of active bleeding.

• Subjects who are on dialysis.

• Subjects who where found to be major protocol violators in A6301083 study.

• Subjects who did not complete the 6 month study period of the A6301083 study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Wien		Austria	A-1090
2	Pfizer Investigational Site	Ransart		Belgium	6043
3	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3A 1R9
4	Pfizer Investigational Site	Praha 5		Czech Republic	150 06
5	Pfizer Investigational Site	Zlin		Czech Republic	760 01
6	Pfizer Investigational Site	Aarhus C		Denmark	8000
7	Pfizer Investigational Site	Karlsbad		Germany	76307
8	Pfizer Investigational Site	Melissia/Athens		Greece	15127
9	Pfizer Investigational Site	Firenze		Italy	50139
10	Pfizer Investigational Site	Tonsberg		Norway	3103
11	Pfizer Investigational Site	Lodz		Poland	90-153
12	Pfizer Investigational Site	Pulawy		Poland	24-100
13	Pfizer Investigational Site	Warszawa		Poland	02-097
14	Pfizer Investigational Site	Wroclaw		Poland	51-124
15	Pfizer Investigational Site	Moscow	Russia	Russian Federation	119034
16	Pfizer Investigational Site	Moscow		Russian Federation	123423
17	Pfizer Investigational Site	Moscow		Russian Federation	127486
18	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	194156
19	Pfizer Investigational Site	Karlstad		Sweden	651 85
20	Pfizer Investigational Site	Malmo		Sweden	205 02
21	Pfizer Investigational Site	Stockholm		Sweden	118 83
22	Pfizer Investigational Site	Stockholm		Sweden	171 76
23	Pfizer Investigational Site	Stockholm		Sweden	182 88
24	Pfizer Investigational Site	Kharkiv		Ukraine	61002
25	Pfizer Investigational Site	Kyiv		Ukraine	02091
26	Pfizer Investigational Site	Lviv		Ukraine	79010
27	Pfizer Investigational Site	Birmingham		United Kingdom	B9 5SS

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00765063
• Other Study ID Numbers: A6301086
• First Posted: Oct 2, 2008
• Last Update Posted: Jan 13, 2012
• Last Verified: Dec 1, 2011

• Keywords provided by Pfizer: Diabetic Foot Ulcers Neuroischaemic
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer; Dalteparin

Study Results

Participant Flow

Recruitment Details	This was a follow-up study of A6301083 (NCT00662831)

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Period Title: Overall Study
STARTED	62
COMPLETED	30
NOT COMPLETED	32

Baseline Characteristics

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Participants	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.2 (11.0)
Sex: Female, Male (Count of Participants)
Female	16 25.8%
Male	46 74.2%

Outcome Measures

1. Primary Outcome

Title	Number of All Hemorrhages
Description	Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater 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	Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)

Outcome Measure Data

Analysis Population Description

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Hemorrhages]	3

2. Primary Outcome

Title	Number of Major Hemorrhages
Description	Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater 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).
Time Frame	Baseline to Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Hemorrhages]	0

3. Primary Outcome

Title	Number of Minor Hemorrhages
Description	Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Time Frame	Baseline to Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Hemorrhages]	3

4. Primary Outcome

Title	Number of Clinically Relevant Minor 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.
Time Frame	Baseline to Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Hemorrhages]	2

5. Primary Outcome

Title	Number of Trivial Hemorrhages
Description	Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.
Time Frame	Baseline to Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

Safety analysis population included all participants who were known to have taken at least one dose of the study medication.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Hemorrhages]	1

6. Secondary Outcome

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. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.
Time Frame	Baseline through Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population included all participants who were enrolled into the study.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Participants]	19 30.6%

7. Secondary Outcome

Title	Number of Participants With Improved Ulcer Healing
Description	Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.
Time Frame	Baseline through Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were enrolled into the study.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Number [Participants]	25 40.3%

8. Secondary Outcome

Title	Number of Participants Who Underwent 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	Baseline through Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were enrolled into the study.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
All amputations (major and minor)	1 1.6%
Major Amputation	1 1.6%
Minor Amputation	0 0%

9. Secondary Outcome

Title	Time to Intact Skin Healing
Description	Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Time Frame	Baseline through Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	0

10. Secondary Outcome

Title	Time to First Amputation
Time Frame	Baseline through Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	0

11. Secondary Outcome

Title	Number of Participants With Major Cardiovascular Disease Events (MCVE)
Description	MCVE 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	Baseline through Week 24 (EOT) or ET

Outcome Measure Data

Analysis Population Description

The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	0

12. Secondary Outcome

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 ET

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were enrolled into the study.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Baseline	2.4 (2.1)
EOT	2.2 (2.1)

13. Secondary Outcome

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 ET

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Measure Participants	62
Baseline: Physical Functioning (n= 43)	34.7 (11.7)
Baseline: Role-Physical (n= 43)	36.5 (10.7)
Baseline: Bodily Pain (n= 43)	45.1 (9.6)
Baseline: General Health (n= 43)	44.1 (4.5)
Baseline: Visibility (n= 43)	48.1 (5.7)
Baseline: Social Functioning (n= 43)	34.3 (7.6)
Baseline: Role-Emotional (n= 43)	36.6 (13.8)
Baseline: Mental Health (n= 43)	42.1 (6.4)
Baseline: Physical (PCS) (n= 43)	40.1 (7.7)
Baseline: Mental (MCS) (n= 43)	41.4 (7.2)
EOT: Physical Functioning (n= 57)	34.8 (11.2)
EOT: Role-Physical (n= 57)	35.1 (11.0)
EOT: Bodily Pain (n= 57)	45.5 (11.3)
EOT: General Health (n= 57)	42.9 (4.6)
EOT: Visibility (n= 57)	48.7 (6.3)
EOT: Social Functioning (n= 57)	35.1 (4.5)
EOT: Role-Emotional (n= 57)	36.3 (14.9)
EOT: Mental Health (n= 57)	42.2 (7.1)
EOT: Physical (PCS) (n= 57)	39.4 (9.0)
EOT: Mental (MCS) (n= 57)	41.9 (7.9)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
All Cause Mortality
	Dalteparin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dalteparin
	Affected / at Risk (%)	# Events
Total	11/62 (17.7%)
Blood and lymphatic system disorders
Anaemia	1/62 (1.6%)
Cardiac disorders
Cardiac failure	1/62 (1.6%)
Cardiac failure acute	1/62 (1.6%)
Myocardial infarction	1/62 (1.6%)
Infections and infestations
Cellulitis	2/62 (3.2%)
Erysipelas	1/62 (1.6%)
Gangrene	1/62 (1.6%)
Infected skin ulcer	1/62 (1.6%)
Pneumonia	2/62 (3.2%)
Urinary tract infection	1/62 (1.6%)
Injury, poisoning and procedural complications
Fall	1/62 (1.6%)
Femoral neck fracture	1/62 (1.6%)
Metabolism and nutrition disorders
Hypoglycaemia	1/62 (1.6%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/62 (1.6%)
Nervous system disorders
Carpal tunnel syndrome	1/62 (1.6%)
Other (Not Including Serious) Adverse Events
	Dalteparin
	Affected / at Risk (%)	# Events
Total	26/62 (41.9%)
Blood and lymphatic system disorders
Anaemia	1/62 (1.6%)
Cardiac disorders
Atrial fibrillation	1/62 (1.6%)
Cardiac failure	2/62 (3.2%)
Ear and labyrinth disorders
Vertigo	1/62 (1.6%)
Endocrine disorders
Hypothyroidism	1/62 (1.6%)
Eye disorders
Panophthalmitis	1/62 (1.6%)
Gastrointestinal disorders
Abdominal pain	1/62 (1.6%)
Diarrhoea	2/62 (3.2%)
Haemorrhoidal haemorrhage	1/62 (1.6%)
Nausea	2/62 (3.2%)
General disorders
Oedema peripheral	1/62 (1.6%)
Ulcer haemorrhage	1/62 (1.6%)
Infections and infestations
Cystitis	1/62 (1.6%)
Diabetic foot infection	3/62 (4.8%)
Erysipelas	2/62 (3.2%)
Folliculitis	1/62 (1.6%)
Infected skin ulcer	1/62 (1.6%)
Nasopharyngitis	4/62 (6.5%)
Orchitis	1/62 (1.6%)
Pneumonia	1/62 (1.6%)
Respiratory tract infection	1/62 (1.6%)
Tooth infection	1/62 (1.6%)
Urinary tract infection	1/62 (1.6%)
Wound infection	1/62 (1.6%)
Injury, poisoning and procedural complications
Chest injury	1/62 (1.6%)
Contusion	2/62 (3.2%)
Wound	1/62 (1.6%)
Investigations
Body temperature increased	1/62 (1.6%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	1/62 (1.6%)
Musculoskeletal and connective tissue disorders
Back pain	2/62 (3.2%)
Musculoskeletal pain	1/62 (1.6%)
Osteitis	1/62 (1.6%)
Psychiatric disorders
Sleep disorder	1/62 (1.6%)
Renal and urinary disorders
Urinary retention	1/62 (1.6%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/62 (1.6%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/62 (1.6%)
Diabetic ulcer	2/62 (3.2%)
Dry gangrene	1/62 (1.6%)
Skin discolouration	1/62 (1.6%)
Skin ulcer	4/62 (6.5%)
Urticaria	1/62 (1.6%)
Surgical and medical procedures
Tooth extraction	1/62 (1.6%)
Vascular disorders
Circulatory collapse	1/62 (1.6%)
Hypertensive crisis	1/62 (1.6%)
Intra-abdominal haematoma	1/62 (1.6%)

Limitations/Caveats

Study enrollment was terminated before planned number of participants was obtained. Although randomized participants were allowed to complete entire course of therapy according to protocol and study status was therefore designated as completed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.