Diabetic Foot Ulcers
Conditions
Keywords
Diabetic Foot Ulcers
Brief summary
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
Detailed description
The primary objective of this study is time -to - healing with wound size determination at 12 weeks.
Interventions
DEVICEAPM 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.
OTHERWound Debridement
Wounds debrided in both arms of study
Sponsors
Stryker Trauma and Extremities
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
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: * Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR * ABIs with results of ≥0.7 and ≤1.2, OR * Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg
Exclusion criteria
* Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe. * Patients whose index diabetic foot ulcers are greater than 25cm2. * Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days, * Patients whose serum creatinine levels are 3.0mg/dl or greater. * Patients with a known history of poor compliance with medical treatments. * Patients who have been previously randomized into this study, or are presently participating in another clinical trial * Patients who are currently receiving radiation therapy or chemotherapy. * Patients with known or suspected local skin malignancy to the index diabetic ulcer. * Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center. * Patients diagnosed with autoimmune connective tissues diseases. * Nonrevascularable surgical sites * Active infection at site * Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin * Any pathology that would limit the blood supply and compromise healing; * Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 Weeks | 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 |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Standard Wound Care Standard Wound care (gels, foams, dressings.)
Wound Debridement : Wounds debrided in both arms of study | 19 |
| 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 | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Standard Wound Care | Total | Treatment With Study Device |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 9 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 30 Participants | 14 Participants |
| Region of Enrollment United States | 19 participants | 39 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 25 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 19 | 3 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
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
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment With Study Device | 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 Wound Care | 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 | 3.33 mm^3 |