Skip to content

The additional effect of SW 112 (wound irrigation solution) combined with regular wond treatment on the bacterial load of chronic foot ulcera: a pilot randomized controlled trial

The additional effect of SW 112 (wound irrigation solution) combined with regular wond treatment on the bacterial load of chronic foot ulcera: a pilot randomized controlled trial - SW112

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42583
Enrollment
Unknown
Registered
2016-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic wounds: chronic ulcera

Interventions

The patients received the regular wound treatment procedures at the policlinic and during home treatment. Additionally in order to test this new device the product will be applied every day 10 minut

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • New (diabetic) patients with neuroischemic and neuropathic foot ulcera • it should we a so-called "wet" wound • Only 1 (new) wound per patiënt is included in the treatment: in case of several wounds the mos severe will be selected for treatment.

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

MeasureTime frame
Primary study parameters: Does SW 112 (wound irrigation/rinsing solution) reduces the bacterial load in (chronic) infected foot ulcera of diabetic patients when is it added to the regular wound treatment of the diabetic patients?

Secondary

MeasureTime frame
Secundary study parameters 1. Does SW 112 (wound irrigation/rinsing solution) when is it added to the regular wound treatment of the diabetic patients induces a change in specification of the wound? 2. Do the patients experience pain sensation when the product SW 112 (pH= 8) is added to the regular wound treatment?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)