Diabetic Foot Ulcers
Conditions
Keywords
Wound closure, Accelerated healing
Brief summary
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers. The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.
Interventions
DEVICEMoist Wound Therapy
Moist Wound Therapy (Standard of Care)
DEVICEVAC Therapy
VAC Therapy
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.) * DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E) * Evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or ABIs with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg. * Age ≥ 18 years of age * HbA1c ≤ 12% (collected within the last 90 days.) * Evidence of adequate nutrition by one of the following: * Lab results reflecting Pre-Albumin \>16 mg/dl and Albumin level is \>3 g/dl (during the seven days prior to the study period), or a nutritional consult will be done and with appropriate supplementation started. Proper documentation on CRFs is needed.
Exclusion criteria
* Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group * Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency * Untreated infection or cellulites at site of target ulcer * Presence of untreated osteomyelitis * Collagen vascular disease * Malignancy in the ulcer * Presence of necrotic tissue * Uncontrolled hyperglycemia * Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy) * Open amputations * Prior V.A.C. therapy within 30 days. * Current or prior normothermic (Warm-UP®) or HBO therapy within 30 days. * Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren) * Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days. * Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study * Pregnant or nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Complete Ulcer Closure Closure. | Days 0-114 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAC Therapy Treatment of Diabetic Foot Ulcers with VAC Therapy
VAC Therapy: VAC Therapy | 169 |
| Moist Wound Therapy Moist Wound Therapy (standard of care)
Moist Wound Therapy: Moist Wound Therapy (Standard of Care) | 166 |
| Total | 335 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 22 | 19 |
| Overall Study | Death | 3 | 4 |
| Overall Study | Exclusionary Methods | 1 | 2 |
| Overall Study | Incomplete Data | 4 | 3 |
| Overall Study | Lack of Efficacy | 8 | 13 |
| Overall Study | Lost to Follow-up | 22 | 19 |
| Overall Study | Non-compliance | 7 | 0 |
| Overall Study | Physician Decision | 14 | 13 |
| Overall Study | Withdrawal by Subject | 13 | 13 |
Baseline characteristics
| Characteristic | Moist Wound Therapy | Total | VAC Therapy |
|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 11.51 | 58.1 years STANDARD_DEVIATION 11.96 | 57.6 years STANDARD_DEVIATION 12.3 |
| Race/Ethnicity, Customized Race/Ethnicity African American | 22 Participants | 50 Participants | 28 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 100 Participants | 195 Participants | 95 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 40 Participants | 81 Participants | 41 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment Canada | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 162 Participants | 327 Participants | 165 Participants |
| Sex: Female, Male Female | 44 Participants | 72 Participants | 28 Participants |
| Sex: Female, Male Male | 122 Participants | 263 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 169 | 5 / 166 |
| other Total, other adverse events | 112 / 169 | 71 / 166 |
| serious Total, serious adverse events | 59 / 169 | 61 / 166 |
Outcome results
Primary
Incidence of Complete Ulcer Closure Closure.
Time frame: Days 0-114
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 43-56 | 12 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 8-14 | 3 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 57-84 | 21 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 0-7 | 1 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 85-114 | 14 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 15-28 | 8 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 0-114 | 67 Participants |
| VAC Therapy | Incidence of Complete Ulcer Closure Closure. | Days 29-42 | 8 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 0-114 | 44 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 29-42 | 9 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 0-7 | 1 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 8-14 | 2 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 15-28 | 2 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 43-56 | 11 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 57-84 | 10 Participants |
| Moist Wound Therapy | Incidence of Complete Ulcer Closure Closure. | Days 85-114 | 9 Participants |
Comparison: Time Frame: Days 0-114p-value: 0.00795% CI: [1.19, 3.02]Fisher Exact