diabetic foot ulcers Ulcera cruris venosum
Conditions
Interventions
Group 1: SNAP™ Therapy System in conjunction with appropriate offloading and/or compression therapy
Group 2: Standard of Care (advanced moist wound therapy excluding collagen wound dressings) in conju
Sponsors
KCI Europe Holding B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The Subject: 1. is = 18 years of age at the time of informed consent 2. can provide written informed consent for study participation 3. is ambulatory and will be treated in an outpatient setting 4. is willing to return for all scheduled and required study visits (for the prospective arm only) 5. presents with diabetes and a Stage 2 diabetic foot ulcer (Wagner’s scale) that is amenable to an airtight seal (for DFU Subjects only) 6. presents with a venous leg ulcer between the knee and malleoli (for VLU Subjects only) 7. has an ulcer with low to moderate exudate levels 8. has an ulcer that has persisted for = 1 month 9. has an ulcer that is not indicated for skin grafting or has an ulcer for which the Subject will not consent to grafting 10. has an ulcer with a surface area of = 1 cm2 but = 25 cm2 11. has an ulcer that is 30 mmHg, (ii) a skin perfusion pressure > 30mmHg, (iii) an ankle brachial index (ABI) between 0.7 and 1.2, or (iv) triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg 14. (or family caregiver) is capable of understanding the technique in principle, responding appropriately, and rebuilding the negative pressure, if necessary (for the prospective arm only)
Exclusion criteria
Exclusion criteria: The Subject: 1. is pregnant 2. has end-stage renal disease requiring dialysis 3. has uncontrolled hyperglycemia with an HbA1c level > 12% 4. shows evidence of systemic infection such as cellulitis or bacteremia/sepsis 5. has a local infection that is active and uncontrolled 6. has peri-wound skin damage that in the judgement of the treating physician is incompatible with the use of the SNAP™ System adhesive drapes (for the prospective arm only) 7. has a wound that is = 2 years old 8. has a wound with exposed bone, vessels, or tendon 9. has a wound located on any toe other than the hallux (for Subjects with DFUs) 10. has a wound that is bleeding and necrotic 11. has Charcot disease 12. has Calciphylaxis 13. has ulcers resulting from electrical, chemical, or radiation burns 14. has ulcers resulting from collagen vascular disease, ulcer malignancy, sickle cell disease, pyoderma gangrenosum, or untreated osteomyelitis 15. was previously treated with NPWT devices, growth factors, hyperbaric oxygen, or bioengineered tissue products (eg, skin and dermal substitutes) within 30 days of enrollment for the wound under study 16. has a known allergy or hypersensitivity to study materials (eg, SNAP™ dressing or drape) (for the prospective arm only) 17. is being concomitantly medicated with immunosuppressive medications, radiation therapy, or chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of complete wound closures within 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete wound closures at 4, 8 and 12 weeks 2. Percent wound area reduction and wound volume reduction within 4, 8, 12, and 16 weeks 3. Time to complete wound closure | — |
Countries
Germany
Contacts
Public ContactDaniela Weichert
KCI Medizinprodukte GmbH
Outcome results
None listed