EPWUF-KI - Relief of nursing care in the field of wound treatment using the example of diabetic foot syndrome by means of a hybrid AI system

EPWUF-KI - Relief of nursing care in the field of wound treatment using the example of diabetic foot syndrome by means of a hybrid AI system - EPWUFKI_2023

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031731

Enrollment

Registered

2023-08-16

Start date

2023-10-09

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

E11.7

Interventions

Group 1: Integration of a sensor unit in relieving bandages to measure pressure and temperature in patients suffering from diabetic foot syndrome. When predefined maximum pressure values are exceeded,

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: - Type1 diabetes, type2 diabetes or type3 diabetes - Age between 18 years and 85 years - polyneuropathy - pressure ulcer i. Wound plantar and peripheral, pressure related. Bony prominence palpable under wound ii. Pressure ulcers on the heel dorsally - Ulcers stage 1 or 2 according to Wagner or stage 3 after surgical rehabilitation

Exclusion criteria

Exclusion criteria: - Active Charcot foot - Tumor less than five years in remission - Severe mental illness - Severe disease reducing life expectancy below 6 months - Pregnancy in female patients - Stage 3 or higher ulcers after Wagner without surgical repair - Necrotic wound areas at the time of randomization - Peripheral arterial occlusive disease (pAVK) in need of revascularization - Permanent accessibility of the patient is not guaranteed - Willingness to carry a cell phone for the duration of study participation

Design outcomes

Primary

Measure	Time frame
Reduction of visit intervals 7-28 days, aim 14 days) at which an increase in the size of the wound area is noted	—

Secondary

Measure	Time frame
i. Impact on nursing care in terms of competence, job satisfaction, and additional time required. ii.time to wound closure iii. Time to bisection of wound area iv. Proportion of DFU with wound closure within 6 weeks. v. Number of steps (non-inferiority, the system should not limit the number of steps if possible). vi. Pain (numeric rating scale, NRS). vii. Patient reported outcome (PRO): Quality of life (DFS-SF, WundQol, EQ-5D), self-efficacy (PAM 13-D), depressiveness (Brief PHQ). viii. Economic costs/benefits for health care system ix. Economic costs/benefits for affected persons	—

Measure

Time frame

i. Impact on nursing care in terms of competence, job satisfaction, and additional time required. ii.time to wound closure iii. Time to bisection of wound area iv. Proportion of DFU with wound closure within 6 weeks. v. Number of steps (non-inferiority, the system should not limit the number of steps if possible). vi. Pain (numeric rating scale, NRS). vii. Patient reported outcome (PRO): Quality of life (DFS-SF, WundQol, EQ-5D), self-efficacy (PAM 13-D), depressiveness (Brief PHQ). viii. Economic costs/benefits for health care system ix. Economic costs/benefits for affected persons

—

Countries

Germany

Contacts

Public ContactDirk Hochlenert

CID GmbH

dirk.hochlenert@cid-direct.de0221 9731610

Outcome results

None listed

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