Nonhealing Lower Extremity Wounds in Diabetes
Nonhealing Lower Extremity Wounds in Diabetes
In this study, 15 patients (18 ulcers) underwent the informed consent process utilizing an Institutional Review Board-approved Subject Consent Form. After meeting all inclusion criteria and none of the exclusion criteria, each patient was treated with a decellularized-acellular dermal matrix (D-ADM) (DermACELL, LifeNet Health, Virginia Beach, VA). Patients were included if their wounds had persisted for at least 6 weeks (wound duration in the study ranged from 2 months to 5 years with an average of 2 years); showed signs of adequate local blood circulation; and were ≥ 1 cm in area and < 1 cm deep. Other inclusionary criteria included presence of full-thickness wounds to the foot or ankle, secondary to either insulin-dependent or noninsulin-dependent diabetes mellitus; recent HgA1C < 12; and ability to comply with off-loading and dressing change requirements. Exclusionary criteria included patient classification as minors, prisoners, and pregnant women; evidence of clinical infection (unless being treated at the time of D-ADM application); necrotizing fasciitis; deep abscesses in the soft tissue; gas gangrene; need for any additional concomitant dressing materials other than the ones approved for this study; and treatment with a living skin equivalent within the last 4 weeks prior to initiation of D-ADM treatment. Four patients (6 ulcers) were excluded from the analysis because they had either new blister formation or an increase in wound size due to noncompliance with the off-loading instructions. All wounds were noted as healing at the end of the treatment period.
Wounds were thoroughly debrided with a sharp blade. The D-ADM was prepared using a combination of nondenaturing anionic detergent (N-Lauroyl sarcosinate, [NLS]), recombinant endonuclease (Benzonase Nuclease, Merck, EMD Millipore, Darmstadt, Germany), and antibiotics (eg, polymixin B, vancomycin, and lincomycin) and terminally sterilized with a low dosage of gamma irradiation at low temperatures to a Sterility Assurance Level of 10. The D-ADM was trimmed accordingly, applied to the wound, and secured by suture or Steri-strip (3M Health Care Skin & Wound Care, St. Paul, MN) and nonadherent dressing. The nonadherent dressing was covered with moistened gauze and a light compression bandage. Patients were evaluated weekly in the clinic for up to 12 weeks after D-ADM application. The wounds were measured at each visit by a trained clinician. Dressings were left in place for a minimum of 5 days and a maximum of 7 days, and were changed by the clinician at the weekly follow-up visit. Single applications of the D-ADM were employed for each wound, except in 3 cases. The reapplication was due to patient noncompliance with the off-loading requirements in 1 case, and clinician election in 2 cases, in an attempt to increase the rate of healing. Of those 3 cases, 2 wounds exhibited > 95% closure at the end of the treatment period. The other wound had exhibited 93% closure 8 weeks after treatment with the D-ADM, and had reopened when the patient presented for a follow-up visit 9 weeks after treatment. At 12 weeks, the end of treatment, that wound was healing and had almost 50% closure.
Materials and Methods
In this study, 15 patients (18 ulcers) underwent the informed consent process utilizing an Institutional Review Board-approved Subject Consent Form. After meeting all inclusion criteria and none of the exclusion criteria, each patient was treated with a decellularized-acellular dermal matrix (D-ADM) (DermACELL, LifeNet Health, Virginia Beach, VA). Patients were included if their wounds had persisted for at least 6 weeks (wound duration in the study ranged from 2 months to 5 years with an average of 2 years); showed signs of adequate local blood circulation; and were ≥ 1 cm in area and < 1 cm deep. Other inclusionary criteria included presence of full-thickness wounds to the foot or ankle, secondary to either insulin-dependent or noninsulin-dependent diabetes mellitus; recent HgA1C < 12; and ability to comply with off-loading and dressing change requirements. Exclusionary criteria included patient classification as minors, prisoners, and pregnant women; evidence of clinical infection (unless being treated at the time of D-ADM application); necrotizing fasciitis; deep abscesses in the soft tissue; gas gangrene; need for any additional concomitant dressing materials other than the ones approved for this study; and treatment with a living skin equivalent within the last 4 weeks prior to initiation of D-ADM treatment. Four patients (6 ulcers) were excluded from the analysis because they had either new blister formation or an increase in wound size due to noncompliance with the off-loading instructions. All wounds were noted as healing at the end of the treatment period.
Wounds were thoroughly debrided with a sharp blade. The D-ADM was prepared using a combination of nondenaturing anionic detergent (N-Lauroyl sarcosinate, [NLS]), recombinant endonuclease (Benzonase Nuclease, Merck, EMD Millipore, Darmstadt, Germany), and antibiotics (eg, polymixin B, vancomycin, and lincomycin) and terminally sterilized with a low dosage of gamma irradiation at low temperatures to a Sterility Assurance Level of 10. The D-ADM was trimmed accordingly, applied to the wound, and secured by suture or Steri-strip (3M Health Care Skin & Wound Care, St. Paul, MN) and nonadherent dressing. The nonadherent dressing was covered with moistened gauze and a light compression bandage. Patients were evaluated weekly in the clinic for up to 12 weeks after D-ADM application. The wounds were measured at each visit by a trained clinician. Dressings were left in place for a minimum of 5 days and a maximum of 7 days, and were changed by the clinician at the weekly follow-up visit. Single applications of the D-ADM were employed for each wound, except in 3 cases. The reapplication was due to patient noncompliance with the off-loading requirements in 1 case, and clinician election in 2 cases, in an attempt to increase the rate of healing. Of those 3 cases, 2 wounds exhibited > 95% closure at the end of the treatment period. The other wound had exhibited 93% closure 8 weeks after treatment with the D-ADM, and had reopened when the patient presented for a follow-up visit 9 weeks after treatment. At 12 weeks, the end of treatment, that wound was healing and had almost 50% closure.
