Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure

Treatment of Diabetic Foot Wounds by Vacuum-Assisted Closure - DiaFoVAC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000059

Enrollment

300

Registered

2009-07-20

Start date

2009-08-01

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

MedDRA - 10060734: Diabetic foot E10.74 E11.75 E11.74 E10.75

Interventions

Group 1: Vacuum-assisted wound therapy Group 2: Conventional moist wound therapy according to evidence-based guidelines

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1- Diabetes mellitus type I, II or III as defined by the necessity for antidiabetic drugs since >= 12 months 2- All wounds corresponded to University of Texas grade 2 or 3 in depth - either a chronic wound (which is planned to receive surgical debridement) - or an amputation wound (which results from a planned below-ankle amputation because of diabetic foot syndrome) 3- Written informed consent

Exclusion criteria

Exclusion criteria: 1- Untreated or refractory phlegmona or osteomyelitis of the wound 2- Presence of necrotic tissue that cannot be debrided 3- Evidence of inadequate leg perfusion (macroangiopathy) 4- Indication for above-ankle amputation of the same extremity 5- Age <18 years 6- Non compliance 7- Pregnancy

Design outcomes

Primary

Measure	Time frame
Time until complete (100%) wound closure (including photo documentation and blinded assessment) without any need for drainage or dressing	—

Secondary

Measure	Time frame
-Pain in wound area (until wound closure and at 12 months) -Wound size over time (percentage change) -Time until wound bed preparation (i.e. 95% granulation tissue) -Recurrence of wound or ulcer at same site -Number of dressing changes -Length of hospital stay -Time until orthopedic footwear supply possible -Time until return to work -Quality-of-life during treatment -Quality of life after Healing (at 6 and 12 months) -Patient satisfaction -Costs (in and out hospital) -Secondary resections and amputations (incidence and dimension) -Complication rates (local and systemic) -Total complication rate -Mortality of any cause (within 12 months)	—

Measure

Time frame

-Pain in wound area (until wound closure and at 12 months) -Wound size over time (percentage change) -Time until wound bed preparation (i.e. 95% granulation tissue) -Recurrence of wound or ulcer at same site -Number of dressing changes -Length of hospital stay -Time until orthopedic footwear supply possible -Time until return to work -Quality-of-life during treatment -Quality of life after Healing (at 6 and 12 months) -Patient satisfaction -Costs (in and out hospital) -Secondary resections and amputations (incidence and dimension) -Complication rates (local and systemic) -Total complication rate -Mortality of any cause (within 12 months)

—

Countries

Germany

Contacts

Public ContactStefan Sauerland

Private Universität Witten/Herdecke gGmbH Institut für Forschung in der Operativen Medizin (IFOM)

stefan.sauerland@uni-wh.de0221 9895719

Outcome results

None listed

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