Trial Outcomes & Findings for Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers (NCT NCT01353495)
NCT ID: NCT01353495
Last Updated: 2021-06-14
Results Overview
Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
12 Weeks
Results posted on
2021-06-14
Participant Flow
subjects with diabetic wound ulcers were recruited for this study in podiatric wound clinic offices for treatment with the graft or standard wound care. Dates of first enrolled subject was 2010
an ulcer (UT Grade IIIA-D) index ulcers \> than 25cm2 an HgA1c \> 12% within previous 90 days, serum cr 3.0mg/dl known history non-compliance previously into this study, or are in another trial receiving radiation therapy,chemotherapy. known local skin malignancy to the index diabetic ulcer. on anticoagulant medication
Participant milestones
| Measure |
Standard Wound Care
Standard Wound care (gels, foams, dressings.)
Wound Debridement : Wounds debrided in both arms of study
|
Treatment With Study Device
Treatment with Biotape Acelular Dermis Graft
APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
Wound Debridement : Wounds debrided in both arms of study
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Standard Wound Care
n=19 Participants
Standard Wound care (gels, foams, dressings.)
Wound Debridement : Wounds debrided in both arms of study
|
Treatment With Study Device
n=20 Participants
Treatment with Biotape Acelular Dermis Graft
APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
Wound Debridement : Wounds debrided in both arms of study
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksWound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound
Outcome measures
| Measure |
Treatment With Study Device
n=20 Participants
Treatment with Biotape Acelular Dermis Graft
APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
Wound Debridement : Wounds debrided in both arms of study
|
Standard Wound Care
n=19 Participants
Standard Wound care (gels, foams, dressings.)
Wound Debridement : Wounds debrided in both arms of study
|
|---|---|---|
|
Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth
|
2.05 mm^3
Standard Deviation NA
data not available as the PI left the institution. Every attempt was made to locate the data,
|
3.33 mm^3
Standard Deviation NA
data not available as the PI left the institution. Every attempt was made to locate the data,
|
Adverse Events
Standard Wound Care
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment With Study Device
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Wound Care
n=19 participants at risk
Standard Wound care (gels, foams, dressings.)
Wound Debridement : Wounds debrided in both arms of study
|
Treatment With Study Device
n=20 participants at risk
Treatment with Biotape Acelular Dermis Graft
APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
Wound Debridement : Wounds debrided in both arms of study
|
|---|---|---|
|
Infections and infestations
LT HEEL PAIN WITH POSSIBLE ABSCCESS
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
RT FOOT INFECTION WITH OSTEOMYELITIS
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
CELLULITIS TO THE RIGHT FOOT.
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
DEHYDRATION
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
5.3%
1/19 • Number of events 1
|
0.00%
0/20
|
Additional Information
Jonette Hodge, MSN, RN, CCRP, Director, Medical Affairs
Wright Medical Technology, Inc.
Phone: 8002387188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place