SNAP Clinical Efficacy Pilot Study in Diabetic Foot and Venous Leg Ulcer Patients
- Conditions
- diabetic foot ulcersUlcera cruris venosum
- Registration Number
- DRKS00017168
- Lead Sponsor
- KCI Europe Holding B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 14
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 < 10 cm in diameter at the widest point of the wound
12. has an ulcer that is = 2.5 cm in depth
13. has an ulcer with adequate blood perfusion, as indicated by any one of the following: (i) a transcutaneous oxygen measurement of the dorsum of the foot > 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)
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method number of complete wound closures within 16 weeks
- Secondary Outcome Measures
Name Time Method 1. Complete wound closures at 4, 8 and 12 weeks<br><br>2. Percent wound area reduction and wound volume reduction within 4, 8, 12, and 16 weeks<br><br>3. Time to complete wound closure