Treatment of wound healing disorders in patients with diabetic foot syndrome caused by diabetic neuropathy (neuropathic foot), or diabetic angiopathy (gangrene) with the medical device TOXAPREVENT SKIN® skin powder and early detection of a possible wound infection by MEANS of VOC analysis by MCC-IMS

Phase 4

• Conditions: E14.7; T79.3; Post-traumatic wound infection, not elsewhere classified

• Registration Number: DRKS00025056
• Lead Sponsor: FROXIMUN AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Both sexes
Indication according to the target
Healthy skin areas present as a control area
Patients with diabetic neuropathy (neuropathic foot), or diabetic angiopathy (gangrene)

Exclusion Criteria

Severe HKE (cardiovascular disease)
other primarily chronic skin diseases
Higher degree of liver and/or renal failure
higher-grade dementia/ Delir
Septic disease
Lack of compliance
Lack of consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proof that the use of TOXAPREVENT® SKIN skin powder stimulates and accelerates wound healing, accelerates faster granulation and reduction of wound infections, improves treatment quality and shortens treatment time in patients with diabetic foot syndrome.

Secondary Outcome Measures

Name	Time	Method
Proof that reproducibly identical patterns of markers in the IMS spectrum of open wounds and biological samples from the same are detectable, which give safe hints of a bacterial infection and its course.