Diabetic Foot Ulcers
Conditions
Keywords
Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy
Brief summary
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
Detailed description
The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.
Interventions
DEVICEV.A.C. Negative Pressure Wound Therapy System
This is a non-invasive wound treatment system that uses controlled, localized negative pressure to create an environment that promotes wound healing in chronic and acute wounds
Sponsors
KCI USA, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female subjects must be ≥ 18 years of age 2. Subject is willing and able to provide written informed consent and comply with protocol required procedures 3. Subject has a calcaneal, dorsal or plantar diabetic foot ulcer no greater than a Grade 2 on the Wagner Grading System for which ActiV.A.C.® Therapy has been prescribed and requires off loading of the SensaT.R.A.C. PadTM 4. Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2 5. Female subject that is willing to use an effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. Acceptable means of contraception is defined as use of Birth control pills, Depo Provera® , Norplant® , IUD (intrauterine device), Diaphragm with spermicide, Condom with spermicide
Exclusion criteria
1. Subject's wound measures \> 84 cm2 2. Presence of untreated cellulitis 3. Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone) 4. History of radiation to the wound area 5. History of thermal injury in the wound area 6. Known hypersensitivity to any disposable component of the V.A.C.® Therapy system 7. Necrotic tissue with eschar present that cannot be debrided prior to subject enrollment in the study 8. Subject is exhibiting active signs and symptoms of infection of the wound(i.e. increased redness or erythema, increased pain, warmth, purulent drainage) 9. Past or current enrollment in this clinical study or any other clinical study within 30 days 10. Female Subject who is pregnant or is unwilling to use acceptable means of contraception during the duration of her participation in the study 11. Subject exhibits significant peri-wound issues that in the opinion of the investigator can interfere with the study assessments 12. Subject is unable to co-operate with study assessments or has a history of non-compliance with off-loading modalities or has a foot deformity that in the opinion of the investigator does not allow for appropriate dressing application or off loading placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use Assessment | 48-72 hours (+6 hours) time period | Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V.A.C Bridge Dressing This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Multiple interruptions in therapy | 8 |
Baseline characteristics
| Characteristic | V.A.C Bridge Dressing |
|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 13.32 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 12 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 8 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Ease of Use Assessment
Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.
Time frame: 48-72 hours (+6 hours) time period
Population: ITT (Intent to Treat) population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Application | 2-Fair | 3 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Comfortability | 4-Excellent | 20 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Removal | 2-Fair | 1 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Application | 1-Poor | 0 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Application | 3-Good | 14 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Application | 4-Excellent | 13 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Comfortability | 1-Poor | 0 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Comfortability | 2-Fair | 1 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Comfortability | 3-Good | 9 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Removal | 1-Poor | 0 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Removal | 3-Good | 4 Participants |
| VAC GranuFoam Bridge Dressing | Ease of Use Assessment | Ease of Dressing Removal | 4-Excellent | 25 Participants |