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

A Phase 2/3 study testing Fragmin in people with Diabetic Foot Ulcer, run by Pfizer at 27 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: Fragmin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 27 sitesin 14 countries
Study dates: Oct 2008to Oct 2010
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

27 sites in 14 countries.

Country

City, postcode or hospital

27 sites in 14 countries

Sweden5 sites

Pfizer Investigational Site
Karlstad, 651 85
Pfizer Investigational Site
Malmö, 205 02
Pfizer Investigational Site
Stockholm, 118 83
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Stockholm, 182 88

Other trials in Sweden

Poland4 sites

Pfizer Investigational Site
Lodz, 90-153
Pfizer Investigational Site
Puławy, 24-100
Pfizer Investigational Site
Warsaw, 02-097
Pfizer Investigational Site
Wroclaw, 51-124

Other trials in Poland

Russia4 sites

Pfizer Investigational Site
Moscow, Russia, 119034
Pfizer Investigational Site
Moscow, 123423
Pfizer Investigational Site
Moscow, 127486
Pfizer Investigational Site
Saint Petersburg, 194156

Other trials in Russia

Ukraine3 sites

Pfizer Investigational Site
Kharkiv, 61002
Pfizer Investigational Site
Kyiv, 02091
Pfizer Investigational Site
Lviv, 79010

Other trials in Ukraine

Czechia2 sites

Pfizer Investigational Site
Prague, 150 06
Pfizer Investigational Site
Zlín, 760 01

Other trials in Czechia

Austria1 site

Pfizer Investigational Site
Vienna, A-1090

Other trials in Austria

Belgium1 site

Pfizer Investigational Site
Ransart, 6043

Other trials in Belgium

Canada1 site

Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Denmark1 site

Pfizer Investigational Site
Aarhus C, 8000

Other trials in Denmark

Germany1 site

Pfizer Investigational Site
Karlsbad, 76307

Other trials in Germany

Greece1 site

Pfizer Investigational Site
Melissia/Athens, 15127

Other trials in Greece

Italy1 site

Pfizer Investigational Site
Florence, 50139

Other trials in Italy

Norway1 site

Pfizer Investigational Site
Tønsberg, 3103

Other trials in Norway

United Kingdom1 site

Pfizer Investigational Site
Birmingham, B9 5SS

Other trials in United Kingdom

About this study

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

Conditions: Diabetic Foot Ulcer
Being tested: Fragmin
Keywords: Diabetic Foot Ulcers Neuroischaemic
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FragminDrug
Also called Dalteparin sodium
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium

Study groups in NCT00765063
Study group	Role	What they receive
Active	Experimental	Active study treatment Receives: Drug: Fragmin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of All Hemorrhages
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.
Measured: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)
Number of Major Hemorrhages
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).
Measured: Baseline to Week 24 (EOT) or ET
Number of Minor Hemorrhages
Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Measured: Baseline to Week 24 (EOT) or ET
Number of Clinically Relevant Minor 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.
Measured: Baseline to Week 24 (EOT) or ET
Number of Trivial Hemorrhages
Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.
Measured: Baseline to Week 24 (EOT) or ET

Secondary outcomes (8)

Number of Participants With Intact Skin Healing
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.
Measured: Baseline through Week 24 (EOT) or ET
Number of Participants With Improved Ulcer Healing
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.
Measured: Baseline through Week 24 (EOT) or ET
Number of Participants Who Underwent 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.
Measured: Baseline through Week 24 (EOT) or ET
Time to Intact Skin Healing
Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Measured: Baseline through Week 24 (EOT) or ET
Time to First Amputation
Measured: Baseline through Week 24 (EOT) or ET
Number of Participants With Major Cardiovascular Disease Events (MCVE)
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.
Measured: Baseline through Week 24 (EOT) or ET
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.
Measured: Baseline and Week 24 (EOT) or ET
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).
Measured: Baseline and Week 24 (EOT) or ET

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Oct 2010

First posted2 Oct 2008 (estimated)
Study startOct 2008
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00765063
Sponsor's protocol ID: A6301086
Status last verified: Dec 2011
First submitted: 30 Sep 2008
Last updated: 13 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00765063
Acronym / sponsor ID: A6301086
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcers Neuroischaemic
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 13 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active	Experimental	Drug: FragminActive study treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FragminAlso: Dalteparin sodiumPre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium	Drug	Active

Primary outcome

Number of All Hemorrhages
Time frame: 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.
Number of Major Hemorrhages
Time frame: 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).
Number of Minor Hemorrhages
Time frame: Baseline to Week 24 (EOT) or ET
Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Number of Clinically Relevant Minor Hemorrhages
Time frame: 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.
Number of Trivial Hemorrhages
Time frame: 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.

8 secondary outcomes

Number of Participants With Intact Skin Healing
Time frame: Baseline through Week 24 (EOT) or ET
Number of Participants With Improved Ulcer Healing
Time frame: Baseline through Week 24 (EOT) or ET
Number of Participants Who Underwent Amputation
Time frame: Baseline through Week 24 (EOT) or ET
Time to Intact Skin Healing
Time frame: Baseline through Week 24 (EOT) or ET
Time to First Amputation
Time frame: Baseline through Week 24 (EOT) or ET
Number of Participants With Major Cardiovascular Disease Events (MCVE)
Time frame: Baseline through Week 24 (EOT) or ET
11-point Likert Pain Scale
Time frame: Baseline and Week 24 (EOT) or ET
36-Item Short-Form Health Survey (SF-36) Score
Time frame: Baseline and Week 24 (EOT) or ET

Results and safety

Results posted to the registry on 13 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalteparin	62	30

Primary outcome: Number of All Hemorrhages

Time frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET). Number. Unit: Hemorrhages

Measure	Dalteparin n = 62
Value	3

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

Primary outcome: Number of Major Hemorrhages

Time frame: Baseline to Week 24 (EOT) or ET. Number. Unit: Hemorrhages

Measure	Dalteparin n = 62
Value	0

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

Primary outcome: Number of Minor Hemorrhages

Time frame: Baseline to Week 24 (EOT) or ET. Number. Unit: Hemorrhages

Measure	Dalteparin n = 62
Value	3

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

Primary outcome: Number of Clinically Relevant Minor Hemorrhages

Time frame: Baseline to Week 24 (EOT) or ET. Number. Unit: Hemorrhages

Measure	Dalteparin n = 62
Value	2

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

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dalteparin	11 of 62 (17.7%)	26 of 62 (41.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Diabetic Foot Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

27 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fragmin in people with Diabetic Foot Ulcer, run by Pfizer at 27 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Sweden, Poland, Russia, Ukraine, Czechia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of All Hemorrhages (time frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00765063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.