E11.74
Conditions
Interventions
Group 1: NO-DFS is a observational study. The NO-producing gel will be applicated to the patients wound.
Sponsors
Klinik für Kardiologie und Angiologie, Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: - age > 18 - Patiens with DFS (max. 12 weeks) - DFS grade I and II (Wagner) - tcPO2 > 40mmHg - adequate therapy of causal disease, e.g. PAD: revascularization, diabetes mellitus: medical therapy
Exclusion criteria
Exclusion criteria: - drug addiction - Pregnancy/lactation - wound infection - therapy demanding malignoma - medical therapy with NO-donators or sGC-activating agents - therapy with PDE5-inhibitors - CKD stadium IV-V - high-grade liver disfunction - DFS grade III-IV (Wagner) - Toe pressure brachial index 15 % - symptomatic arterial hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - changes in tissue ocygenation during application of nitrite gel (tcPO2) - tcPO2 before and after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - wound-Qol - nitrite/nitrate/ROS in Plasma, oxyHb - microbiological wound culture - Peri-wound skin temperature laser speckle contrast imaging - Peri-wound skin temperature infrared thermography 19 - Bates-Jensen Wound Assessment Tool Score - pain reduction - time to 50%, 75%, 100% wound closure - laser doppler flowmetry - time to total wound healing | — |
Countries
Germany
Contacts
Public ContactChristos Rammos
Klinik für Kardiologie und Angiologie, Universitätsklinikum Essen
Outcome results
None listed