Trial Outcomes & Findings for Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers (NCT NCT00432965)
NCT ID: NCT00432965
Last Updated: 2024-10-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
335 participants
Primary outcome timeframe
Days 0-114
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
VAC Therapy
Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy
|
Moist Wound Therapy
Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care)
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
166
|
|
Overall Study
COMPLETED
|
75
|
80
|
|
Overall Study
NOT COMPLETED
|
94
|
86
|
Reasons for withdrawal
| Measure |
VAC Therapy
Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy
|
Moist Wound Therapy
Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
19
|
|
Overall Study
Withdrawal by Subject
|
13
|
13
|
|
Overall Study
Physician Decision
|
14
|
13
|
|
Overall Study
Lack of Efficacy
|
8
|
13
|
|
Overall Study
Non-compliance
|
7
|
0
|
|
Overall Study
Adverse Event
|
22
|
19
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Exclusionary Methods
|
1
|
2
|
|
Overall Study
Incomplete Data
|
4
|
3
|
Baseline Characteristics
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
VAC Therapy
n=169 Participants
Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy
|
Moist Wound Therapy
n=166 Participants
Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care)
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 11.51 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
263 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
95 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
165 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0-114Population: Analysis of this endpoint was based on the Intent-to-Treat (ITT population). Subjects who signed an informed consent and were randomized, but failed to undergo their assigned randomized treatment, were included in this population.
Outcome measures
| Measure |
VAC Therapy
n=162 Participants
Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy
|
Moist Wound Therapy
n=162 Participants
Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care)
|
|---|---|---|
|
Incidence of Complete Ulcer Closure Closure.
Days 0-7
|
1 Participants
|
1 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 8-14
|
3 Participants
|
2 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 15-28
|
8 Participants
|
2 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 29-42
|
8 Participants
|
9 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 43-56
|
12 Participants
|
11 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 57-84
|
21 Participants
|
10 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 85-114
|
14 Participants
|
9 Participants
|
|
Incidence of Complete Ulcer Closure Closure.
Days 0-114
|
67 Participants
|
44 Participants
|
Adverse Events
VAC Therapy
Serious events: 59 serious events
Other events: 112 other events
Deaths: 4 deaths
Moist Wound Therapy
Serious events: 61 serious events
Other events: 71 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
VAC Therapy
n=169 participants at risk
Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy
|
Moist Wound Therapy
n=166 participants at risk
Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.8%
3/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
3.0%
5/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Eye disorders
Cataract
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Eye disorders
Eye Haemorrhage
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
General disorders
Chest Pain
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
General disorders
Death
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
General disorders
Non-cardiac Chest Pain
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
General disorders
Pyrexia
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Cellulitis
|
7.1%
12/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
6.6%
11/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Osteomyelitis
|
5.3%
9/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
9.6%
16/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Infected Skin Ulcer
|
1.8%
3/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Sepsis
|
1.8%
3/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Bacteraemia
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Central Line Infection
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Gangrene
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
3.0%
5/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Staphylococcal Infection
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Wound Infection
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
3.0%
5/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Abscess
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Abscess Limb
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Catheter Sepsis
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Localised Infection
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.8%
3/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Thrombophlebitis Septic
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Urinary Tract Infection
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Urosepsis
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Infection
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Graft Thrombosis
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Wound Decomposition
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Vascular Graft Complication
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Investigations
Cardiac Enzymes Increased
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.8%
3/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Musculoskeletal and connective tissue disorders
Fracture Nonunion
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic Arthropathy
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
1.2%
2/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Skin and subcutaneous tissue disorders
Neuropathic Ulcer
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Surgical and medical procedures
Hospitalisation
|
0.59%
1/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.00%
0/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Surgical and medical procedures
Wound Debridement
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
0.60%
1/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
1.2%
2/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
Other adverse events
| Measure |
VAC Therapy
n=169 participants at risk
Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy
|
Moist Wound Therapy
n=166 participants at risk
Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care)
|
|---|---|---|
|
General disorders
Oedema Peripheral
|
5.3%
9/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
6.0%
10/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Cellulitis
|
4.7%
8/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
4.8%
8/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Infections and infestations
Wound Infection
|
9.5%
16/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
6.0%
10/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
11.2%
19/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
6.0%
10/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin Maceration
|
59.8%
101/169 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
30.1%
50/166 • Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60