A Proof of Principle Study Investigating the Influence of Diclofenac on Perfusion Changes During Cutaneous Negative Pressure Wound Therapy

A Proof of Principle Study Investigating the Influence of Diclofenac on Perfusion Changes During Cutaneous Negative Pressure Wound Therapy - The DicloFlow study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48444

Enrollment

Registered

2019-04-25

Start date

2019-04-29

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Wonden die behandeld kunnen worden met negatieve druk therapie Wounds

Interventions

Three sessions with Negative Pressure Wound Therapy, once with oral Diclofenac, and once with Diclofenac gel.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Between 18-35 years of age * Informed consent * Male

Exclusion criteria

Exclusion criteria: * Nicotine abuse * Gastro-intestinal complaints * Diclofenac allergy * Cardiovascular disease * Neuropathy * Skin disease of the forearm * Use of drugs outside of those relating to the study

Design outcomes

Primary

Measure	Time frame
8.1.1 Main study parameter/endpoint The main study parameter of this experiment will be the mean LDF flux of the last 5 minutes of the 20-minute -200 mm Hg NPWT period of the thee study arms.	—

Secondary

Measure	Time frame
8.1.2 Secondary study parameters/endpoints (if applicable) The Single Fibre Reflectance Spectroscopy (SFRS) device will provide us with signals that can be used to calculate measures of blood content (), micro-vessel saturation (StO2) and mean microvessel diameter (Dvessel). Because there is only one probe available this probe will be placed beneath the NPWT foam only. It takes 30 seconds to record 10 SFRS recordings. 10 measurements will be made every minute for the 20 minute -200 mm Hg NPWT period. Using both the blood content () and the oxygen saturation of the blood (StO2), oxygenated blood content of the tissue under investigation with SFRS can be calculated. 8.1.3 Other study parameters (if applicable) Sex, age, length, weight and BMI of every participant will be recorded before the experiment. Room temperature will be measured during every measurement session. If a measurement period deviates from normal because of disturbance such as leaks, or if the volunteer wants to quit, this will be recorded and reported appropriately. Any adverse event during or after the experiment will be reported as well.	—

Measure

Time frame

8.1.2 Secondary study parameters/endpoints (if applicable) The Single Fibre Reflectance Spectroscopy (SFRS) device will provide us with signals that can be used to calculate measures of blood content (*), micro-vessel saturation (StO2) and mean microvessel diameter (Dvessel). Because there is only one probe available this probe will be placed beneath the NPWT foam only. It takes 30 seconds to record 10 SFRS recordings. 10 measurements will be made every minute for the 20 minute -200 mm Hg NPWT period. Using both the blood content (*) and the oxygen saturation of the blood (StO2), oxygenated blood content of the tissue under investigation with SFRS can be calculated. 8.1.3 Other study parameters (if applicable) Sex, age, length, weight and BMI of every participant will be recorded before the experiment. Room temperature will be measured during every measurement session. If a measurement period deviates from normal because of disturbance such as leaks, or if the volunteer wants to quit, this will be recorded and reported appropriately. Any adverse event during or after the experiment will be reported as well.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)