Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.
Brief Summary: Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.

Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.

Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.

Primary aim of the study: Complete closure at week 8

Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment

Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed


Options:
A: Arm Label: A: GM-CSF + supervised treadmill exercise therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Supervised Treadmill Exercise Therapy, Drug: granulocyte macrophage colony stimulating factor (GM-CSF) | Arm Label: B: GM-CSF + attention control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Health education sessions (Control), Drug: granulocyte macrophage colony stimulating factor (GM-CSF) | Arm Label: C: placebo + supervised exercise therapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Supervised Treadmill Exercise Therapy | Arm Label: D: placebo + attention control group; Type: PLACEBO_COMPARATOR; Interventions: Other: Health education sessions (Control) | Intervention Type: BEHAVIORAL; Name: Supervised Treadmill Exercise Therapy; Assigned to Arm(s): A: GM-CSF + supervised treadmill exercise therapy, C: placebo + supervised exercise therapy | Intervention Type: OTHER; Name: Health education sessions (Control); Assigned to Arm(s): B: GM-CSF + attention control group, D: placebo + attention control group | Intervention Type: DRUG; Name: granulocyte macrophage colony stimulating factor (GM-CSF); Assigned to Arm(s): A: GM-CSF + supervised treadmill exercise therapy, B: GM-CSF + attention control group
B: Arm Label: GSK1278863 5mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 100mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 100mg, GSK1278863 5mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: becaplermin gel; Type: EXPERIMENTAL; Interventions: Drug: becaplermin gel | Arm Label: Duoderm Hydrogel™; Type: ACTIVE_COMPARATOR; Interventions: Drug: Duoderm Hydrogel™ | Intervention Type: DRUG; Name: becaplermin gel; Assigned to Arm(s): becaplermin gel | Intervention Type: DRUG; Name: Duoderm Hydrogel™; Assigned to Arm(s): Duoderm Hydrogel™
D: Arm Label: Riferminogene pecaplasmid; Type: EXPERIMENTAL; Interventions: Biological: riferminogene pecaplasmid | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo (for riferminogene pecaplasmid) | Intervention Type: BIOLOGICAL; Name: riferminogene pecaplasmid; Assigned to Arm(s): Riferminogene pecaplasmid | Intervention Type: BIOLOGICAL; Name: Placebo (for riferminogene pecaplasmid); Assigned to Arm(s): Placebo

Answer: C