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Study no longer met business objectives
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A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC NPWT | Active Comparator |
| |
| Gauze-Based NPWT | Active Comparator |
| |
| Moist Wound Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powered Suction Pump (VAC Freedom) | Device | continuous foam based negative pressure wound therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Energy Charge Between Wound Treatment Therapies | Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate | Day 0, Day 2, Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gayle M Gordillo, MD | Ohio State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States | ||
| University of Texas Health Science Center San Antonio |
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| ID | Title | Description |
|---|---|---|
| FG000 | VAC NPWT | Powered Suction Pump (VAC Freedom): continuous suction, foam based negative pressure wound therapy |
| FG001 | Gauze-Based NPWT | Powered Suction Pump: continuous suction; gauze based negative pressure wound therapy |
| FG002 | Moist Wound Therapy | MWT: moist wound therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VAC NPWT | Powered Suction Pump (VAC Freedom): continuous suction |
| BG001 | Gauze-Based NPWT | Powered Suction Pump: continuous suction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compare Energy Charge Between Wound Treatment Therapies | Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate | Energy charge data was not available for all subjects on the study. Data was only recorded for the subjects listed above. | Posted | Mean | Standard Deviation | Ratio | Day 0, Day 2, Day 7 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAC NPWT | Powered Suction Pump (VAC Freedom): continuous suction | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Maceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Global Clinical Development | KCI, an Acelity Company | 210-255-5595 | jane.hart@kci1.com |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Powered Suction Pump | Device | continuous gauze based negative pressure wound therapy |
|
|
| MWT | Device | moist wound therapy |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| BG002 | Moist Wound Therapy | MWT: moist wound therapy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Powered Suction Pump: continuous suction
| OG002 | Moist Wound Therapy | MWT: moist wound therapy |
|
|
| 20 |
| 4 |
| 20 |
| 12 |
| 20 |
| EG001 | Gauze-Based NPWT | Powered Suction Pump: continuous suction | 0 | 21 | 1 | 21 | 9 | 21 |
| EG002 | Moist Wound Therapy | MWT: moist wound therapy | 0 | 9 | 2 | 9 | 3 | 9 |
| Staphylococcal Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Infected Skin Ulcer | Infections and infestations | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Haemaglobin decreased | Investigations | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Panniuculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Localised Infection | Infections and infestations | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Wound Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| International Normalised Ratio Increased | Investigations | Systematic Assessment |
|
| Urine Output Decreased | Investigations | Systematic Assessment |
|
| Red Cell Distribution Width Increased | Investigations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Shock Hypoglycaemic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Wound Drainage | Surgical and medical procedures | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |