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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00765063

First received: September 30, 2008

Last updated: December 1, 2011

Last verified: December 2011

History of Changes

Results First Received: August 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetic Foot Ulcer
Intervention:	Drug: Fragmin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a follow-up study of A6301083 (NCT00662831)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Dalteparin	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.

Participant Flow: Overall Study

	Dalteparin
STARTED	62
COMPLETED	30
NOT COMPLETED	32
Lack of Efficacy	5
Withdrawal by Subject	1
Unspecified	16
Protocol Violation	6
Adverse Event	4

Baseline Characteristics

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Reporting Groups

	Description
Dalteparin	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.

Baseline Measures

	Dalteparin
Number of Participants [units: participants]	62
Age [units: years] Mean ± Standard Deviation	65.2 ± 11.0
Gender [units: participants]
Female	16
Male	46

Outcome Measures

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1. Primary:

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

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2. Primary:

Number of Major Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]

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3. Primary:

Number of Minor Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]

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4. Primary:

Number of Clinically Relevant Minor Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]

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5. Primary:

Number of Trivial Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]

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6. Secondary:

Number of Participants With Intact Skin Healing [ Time Frame: Baseline through Week 24 (EOT) or ET ]

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7. Secondary:

Number of Participants With Improved Ulcer Healing [ Time Frame: Baseline through Week 24 (EOT) or ET ]

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8. Secondary:

Number of Participants Who Underwent Amputation [ Time Frame: Baseline through Week 24 (EOT) or ET ]

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9. Secondary:

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

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10. Secondary:

Time to First Amputation [ Time Frame: Baseline through Week 24 (EOT) or ET ]

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11. Secondary:

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

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12. Secondary:

11-point Likert Pain Scale [ Time Frame: Baseline and Week 24 (EOT) or ET ]

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13. Secondary:

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

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Serious Adverse Events

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Time Frame	No text entered.
Additional 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.

Reporting Groups

	Description
Dalteparin	Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.

Serious Adverse Events

	Dalteparin
Total, serious adverse events
# participants affected / at risk	11/62 (17.74%)
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Cardiac disorders
Cardiac failure ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Cardiac failure acute ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Myocardial infarction ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Infections and infestations
Cellulitis ^{* 1}
# participants affected / at risk	2/62 (3.23%)
Erysipelas ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Gangrene ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Infected skin ulcer ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Pneumonia ^{* 1}
# participants affected / at risk	2/62 (3.23%)
Urinary tract infection ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Injury, poisoning and procedural complications
Fall ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Femoral neck fracture ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Metabolism and nutrition disorders
Hypoglycaemia ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Musculoskeletal and connective tissue disorders
Pain in extremity ^{* 1}
# participants affected / at risk	1/62 (1.61%)
Nervous system disorders
Carpal tunnel syndrome ^{* 1}
# participants affected / at risk	1/62 (1.61%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 13.1

Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00765063 History of Changes
Other Study ID Numbers:	A6301086
Study First Received:	September 30, 2008
Results First Received:	August 11, 2011
Last Updated:	December 1, 2011
Health Authority:	Spain: Ethics Committee

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