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

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 - MANC-MCC-IMS-202005

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025056

Enrollment

Registered

2021-04-14

Start date

2021-04-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E14.7 T79.3

Interventions

Group 1: Verum: 25 patients (wound and healthy skin), local treatment with TOXAPREVENT SKIN skin powder. Group 2: Control: 25 patients (wound and healthy skin), local treatment, conventional treatment

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactMario Kuhnert

Asklepios Klinik

m.kuhnert@asklepios.de+4933035220

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026