Trial · NCT00662831
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
NCT00662831, Phase 2, Phase 3, Completed, Pfizer; results first posted 2012-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients. Trials, record NCT00662831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00662831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
- NCT number
- NCT00662831
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 276 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Fragmin/ Dalteparin Sodium, Placebo for Fragmin/ Dalteparin Sodium
- First posted
- 2008-04-21
- Last updated
- 2018-12-19
- Results first posted
- 2012-01-13
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Week 24 [end of treatment (EOT)] or early termination | 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 | Number of Participants With Intact Skin Healing | Week 24 (EOT) or early termination | 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. |
| Secondary | Number of Participants Who Underwent Any Amputation | Week 24 (EOT) or early termination | 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. |
| Secondary | Number of Participants Who Underwent Major and Minor Amputation | Week 24 (EOT) or early termination | 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. |
| Secondary | Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing | Week 24 (EOT) or early termination | 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 | Number of Participants Who Died | Week 24 (EOT) or early termination | |
| Secondary | Number of Participants With Major Cardiovascular Disease Events (MCVE) | Week 24 (EOT) or early termination | 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. |
| Secondary | Time to Intact Skin Healing | Week 24 (EOT) or early termination | Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation. |
| Secondary | Median Time to First Amputation | Week 24 (EOT) or early termination | |
| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score | Baseline and Week 24 (EOT or early termination) | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Week 24 [end of treatment (EOT)] or early termination | Intention to treat (ITT) population included all participants who were randomized. Last observation carried forward (LOCF) method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | participants | NUMBER |
| SECONDARY | Number of Participants With Intact Skin Healing | Week 24 (EOT) or early termination | ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | participants | NUMBER |
| SECONDARY | Number of Participants Who Underwent Any Amputation | Week 24 (EOT) or early termination | ITT population included all participants who were randomized. | participants | NUMBER |
| SECONDARY | Number of Participants Who Underwent Major and Minor Amputation | Week 24 (EOT) or early termination | ITT population included all participants who were randomized. | participants | NUMBER |
| SECONDARY | Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing | Week 24 (EOT) or early termination | ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | participants | NUMBER |
| SECONDARY | Number of Participants Who Died | Week 24 (EOT) or early termination | ITT population included all participants who were randomized. | participants | NUMBER |
| SECONDARY | Number of Participants With Major Cardiovascular Disease Events (MCVE) | Week 24 (EOT) or early termination | The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained. | ||
| SECONDARY | Time to Intact Skin Healing | Week 24 (EOT) or early termination | The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained. | ||
| SECONDARY | Median Time to First Amputation | Week 24 (EOT) or early termination | The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained. | ||
| SECONDARY | Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score | Baseline and Week 24 (EOT or early termination) | ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Units on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Dalteparin | Stratum 1 (n= 97, 49) | 68 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Placebo | Stratum 1 (n= 97, 49) | 31 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Dalteparin | Stratum 2 (n= 39, 19) | 23 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Placebo | Stratum 2 (n= 39, 19) | 14 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Dalteparin | Stratum 3 (n= 29, 14) | 21 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Placebo | Stratum 3 (n= 29, 14) | 10 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Dalteparin | Stratum 4 (n= 19, 10) | 9 | participants | |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | Placebo | Stratum 4 (n= 19, 10) | 6 | participants | |
| Number of Participants With Intact Skin Healing | Dalteparin | Stratum 1 (n= 97, 49) | 35 | participants | |
| Number of Participants With Intact Skin Healing | Placebo | Stratum 1 (n= 97, 49) | 16 | participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalteparin | 184 | |
| Overall Study | STARTED | Placebo | 92 | |
| Overall Study | COMPLETED | Dalteparin | 78 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | NOT COMPLETED | Dalteparin | 106 | |
| Overall Study | NOT COMPLETED | Placebo | 59 |
Source ClinicalTrials.gov
Adverse events356
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dalteparin | 1 | 184 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 92 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Dalteparin | 0 | 184 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Placebo | 1 | 92 | |
| other | Monocytopenia | Blood and lymphatic system disorders | Dalteparin | 1 | 184 | |
| other | Monocytopenia | Blood and lymphatic system disorders | Placebo | 1 | 92 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Dalteparin | 1 | 184 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Placebo | 0 | 92 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Dalteparin | 1 | 184 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Placebo | 0 | 92 |
1 to 10 of 356Source ClinicalTrials.gov
See all 356 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalteparin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dalteparin | 76 | 184 |
| Total, other adverse events | Placebo | 36 | 92 |
| Total, serious adverse events | Dalteparin | 33 | 184 |
| Total, serious adverse events | Placebo | 18 | 92 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dalteparin vs Placebo: Number of Participants Who Underwent Any Amputation | Trial comparisons |
| Dalteparin vs Placebo: Number of Participants Who Died | Trial comparisons |
| Dalteparin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00662831
GET https://conductscience.org/api/trials/v1/NCT00662831/results?page=2