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NCT01774058: ILOFLOW

The Intraoperative Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation in Diabetics and Non-diabetics: Implication for Outcome-prediction and Perioperative Therapy

Status unknown Phase 2 Last updated 16 October 2018
What this trial tests

Phase 2 trial testing Ilomedin in Diabetes in 100 participants. Status unknown.

Timeline
1 October 2012
Primary endpoint
1 June 2019
1 June 2019

Quick facts

Lead sponsorPrim PD Dr Afshin Assadian
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment100
Start date1 October 2012
Primary completion1 June 2019
Estimated completion1 June 2019
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Prim PD Dr Afshin Assadian — full company profile →

Who can join

18 and older, any sex, with Diabetes or Arteriosclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

A prospective case-control study was performed to investigate the effect of iloprost on the intraoperative flow volume in diabetic and non-diabetic patients as well as the effect of peripheral neuropathy in patients with peripheral arterial occlusive disease (PAOD) undergoing arterial reconstruction (primary endpoint). 100 patients undergoing femoral artery reconstruction or femorodistal bypass surgery were included. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow volume at the common femoral artery was assessed using a Doppler flowmeter (Sono TT FlowLab; ) before reconstruction, prior to the intraarterial application of 3000ng of iloprost and 5 and 10 minutes afterwards. Peripheral resistance units (PRU) were calculated as a function of mean systemic arterial pressure (MAP) and flow volume (VF): PRU = MAP (mmHg) / VF (ml/min).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01774058.