Study to evaluate the improvement of leg's circulation through growth hormone (GH) treatment.

• Conditions: ower limb critical ischemia; MedDRA version: 18.0Level: LLTClassification code 10023034Term: Ischemia peripheralSystem Organ Class: 100000004866; MedDRA version: 18.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866; MedDRA version: 18.0Level: LLTClassification code 10066920Term: Leg ischemiaSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002228-34-ES
• Lead Sponsor: Diego Caicedo Valdés

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-14
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with lower limbs critical ischemia by mean: trophic lesions and/or rest pain and/or night pain of ischemic origin and ankle-brachial index (ABI) equal or lower than 0.4
Failed previous attempts of revascularization through main methods: surgical and/or endovascular therapies.
High risk of loss limb
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Fertile women
Aged under 18
Legally incapable
Onchologic patients
Sepsis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the angiogenic efficacy and the safety of subcutaneus growth hormone (sGH) on patients with lower limb critical ischemia;Secondary Objective: To determine the onset time of angiogenic action of sGH after injection<br>To compare the severity of peripheral artery disease among treatment groups (sGH and placebo) according to protocol tests at time 0, 30 days and 60 days (end of treatment)<br>To evaluate long term effects of sGH after end of treatment (1 year)<br>To evaluate the safety of sGH treatment through adverse events description.;Primary end point(s): Photopletismography (wave in milimeters);Timepoint(s) of evaluation of this end point: 0 days<br>30 days<br>60 days<br>1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Doppler study: systolic speed, diastolic speed, pulsatility index, ABI, morphological analysis of the curve<br>Angio-CT;Timepoint(s) of evaluation of this end point: 0 days<br>30 days (except angioCT)<br>60 days<br>1 year (except angioCT)