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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
Phase 2 trial testing Ilomedin in Diabetes in 100 participants. Status unknown.
1 June 2019
Quick facts
| Lead sponsor | Prim PD Dr Afshin Assadian |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 October 2012 |
| Primary completion | 1 June 2019 |
| Estimated completion | 1 June 2019 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Ilomedin — full drug profile →
Conditions studied
- Diabetes — all drugs for Diabetes →
- Arteriosclerosis — all drugs for Arteriosclerosis →
- Peripheral Arterial Occlusive Disease — all drugs for Peripheral Arterial Occlusive Disease →
- Neuropathy — all drugs for Neuropathy →
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.
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The measurement of the blood flow volume is done with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument on the common femoral artery in diabetics and non-diabetics after ilomedin administration.
Time frame: 6 weeks after surgery
Before surgery reconstruction the first measurement with the Sono TT FlowLab (em-Tec GmbH, Munich) ultrasound instrument will be done on the common femoral artery and then after surgery reconstruction. Therefore there will be different measuring heads exactly fitting around the vessels. Then the administration of 3000ng Ilomedin® in 15ml saline will be injected into the common femoral artery via a
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.
Verify or expand the search:
- PubMed search for NCT01774058
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01774058 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prim PD Dr Afshin Assadian
- Last refreshed: 16 October 2018
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.