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Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
The primary objective of this study is time -to - healing with wound size determination at 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APM Graft (BIOTAPE XMTM | Experimental | graft applied to wound q 3 weeks for 12 weeks |
|
| standard wound care | Active Comparator | Wound debridement and gels and foams applied to wound weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APM Graft (BIOTAPE XMTM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 Weeks |
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Inclusion Criteria:
Inclusion Criteria and Population:
Male or female age 18 or older
Informed consent must be obtained
Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
Patient's ulcer must exhibit no clinical signs of infection.
Patient is of legal consenting age.
Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jagpreet Mukker, DPM | Advanced Foot Care and Clinincal Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Foot Care and Clinincal Research Center | Fresno | California | 93722 | United States | ||
| Professional Education & Research Institute |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Wound Care | Standard Wound care (gels, foams, dressings.) Wound Debridement : Wounds debrided in both arms of study |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Wound Care | Standard Wound care (gels, foams, dressings.) Wound Debridement : Wounds debrided in both arms of study |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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 | 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 | Posted | Mean | Standard Deviation | mm^3 | 12 Weeks |
|
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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 | Standard Wound Care | Standard Wound care (gels, foams, dressings.) Wound Debridement : Wounds debrided in both arms of study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LT HEEL PAIN WITH POSSIBLE ABSCCESS | Infections and infestations | Systematic Assessment | DEVELOPING PAIN LEFT HEEL OVER PAST FEW DAys; MILD FOWL ODOR &TENDERNESS. ? INFECTION IN THE HEEL. Reported as possibly related to procedure Final report was resolved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonette Hodge, MSN, RN, CCRP, Director, Medical Affairs | Wright Medical Technology, Inc. | 8002387188 | 4747 | jonette.hodge@wmt.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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|
|
| Wound Debridement | Other | Wounds debrided in both arms of study |
|
| Roanoke |
| Virginia |
| 24016 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard Wound Care | Standard Wound care (gels, foams, dressings.) Wound Debridement : Wounds debrided in both arms of study |
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| EG001 | 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 | 0 | 20 | 3 | 20 |
|
| RT FOOT INFECTION WITH OSTEOMYELITIS | Infections and infestations | Systematic Assessment | TO HOSPITAL. CELLULITIS RT LEG, FOOT, WAS PLACED ON IV ABX, BONE SCAN ; POSITIVE OSTEOMYELITIS. Reported as possibly related to procedure final eport: resolved reported as possibly related to the device; then reported as resolved |
|
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | PT STARTED EXPERIENCING INCREASING SOB AND COUGHING AND DECIDED TO GO TO ER TO ENSURE NOTHING WAS WRONG. Not related to the device or the procedure Outcome Resolved |
|
| CELLULITIS TO THE RIGHT FOOT. | Infections and infestations | Systematic Assessment | SUBJECT HAVING FEVER, CHILLES, AND PAIN. Reported: not related to device or procedure final report: resolved |
|
| DEHYDRATION | Gastrointestinal disorders | Systematic Assessment | SUBJECT FELL ILL DUE TO FOOD POISONING AND WAS ADMITTED FOR DEHYDRATION OVER THE WEEKEND. reported as unrelated to device or procedure Outcome: resolved |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | SUBJECT WAS HAVING PROBLEM BREATHING Reported as mild Reported as unrelated to device or procedure Reported as Ongoing at the end of the study |
|
| DEHYDRATION | Gastrointestinal disorders | Systematic Assessment | SUBJECT FELL ILL DUE TO FOOD POISONING ADMITTED FOR DEHYDRATION OVER THE WEEKEND. Reported as not related to device or procedure final outcome resolved. One foot standard of care other Biotape used |
|
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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 |