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

Growth hormone (GH) angiogenic effect clinical trial on patients with lower limb critical ischemia. GHAS Study - GHAS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002228-34-ES
Enrollment
Unknown
Registered
2012-09-14
Start date
2015-09-30
Completion date
Unknown
Last updated
2015-10-12

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

Conditions

Lower limb critical ischemia MedDRA version: 18.0 Level: LLT Classification code 10023034 Term: Ischemia peripheral System Organ Class: 100000004866 MedDRA version: 18.0 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866 MedDRA version: 18.0 Level: LLT Classification code 10066920 Term: Leg ischemia System Organ Class: 100000004866

Interventions

Trade Name: Genotonorm Product Name: Genotonorm Product Code: 61815 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: somatropina Other descriptive name: RECOMBIN

Sponsors

Diego Caicedo Valdés
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Fertile women Aged under 18 Legally incapable Onchologic patients Sepsis

Design outcomes

Primary

MeasureTime frame
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 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) To evaluate long term effects of sGH after end of treatment (1 year) 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 30 days 60 days 1 year—

Secondary

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

Countries

Spain

Contacts

Public ContactUnidad de Apoyo a la Investigación

Fundación Biomédica Galicia Sur

marta.olivares.parada@sergas.es0034986800949

Outcome results

None listed

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