Trial Outcomes & Findings for Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers (NCT NCT00399308)

NCT ID: NCT00399308

Last Updated: 2021-06-11

Results Overview

The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-06-11

Participant Flow

An enrollment of 55 patients was planned to produce an expected yield of approximately 45 evaluable patients at up to nine study centers.

72 patients were consented in this study. Eighteen failed screening: eight had HbA1c > 7%; six failed wound size criteria; one was positive for HIV; one had a normal venous ultrasound; and two withdrew consent. Of the remaining 54 patients, 14 were not randomized: 11 healed > 50% during screening; one had a severe AE; and two more withdrew.

Participant milestones

Measure	Group II - Bi-weekly Celaderm Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control Adaptic and Profore four-layer compression dressing	Group I - Weekly Celaderm Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
Overall Study STARTED	15	12	13
Overall Study COMPLETED	15	11	13
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

Baseline characteristics by cohort

Measure	Group I - Weekly Celaderm n=13 Participants Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=15 Participants Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=12 Participants Adaptic and Profore four-layer compression dressing	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Age, Continuous	67.54 years STANDARD_DEVIATION 12.65 • n=5 Participants	60.40 years STANDARD_DEVIATION 8.75 • n=7 Participants	64 years STANDARD_DEVIATION 12.85 • n=5 Participants	65.28 years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Region of Enrollment United States	13 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	40 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intent-to-Treat population (i.e. all subjects randomized to treatment)

The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)

Outcome measures

Measure	Group I - Weekly Celaderm n=13 Participants Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=15 Participants Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=12 Participants Adaptic and Profore four-layer compression dressing
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.	1 participants	4 participants	3 participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Intent-to-Treat population

Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.

Outcome measures

Measure	Group I - Weekly Celaderm n=13 Participants Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=15 Participants Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=12 Participants Adaptic and Profore four-layer compression dressing
Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.	1 participants	5 participants	3 participants

SECONDARY outcome

Timeframe: Variable - minimum of 12 weeks of follow-up.

Population: Intent-to-treat population achieving primary outcome

The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.

Outcome measures

Measure	Group I - Weekly Celaderm n=1 Participants Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=4 Participants Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=3 Participants Adaptic and Profore four-layer compression dressing
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Intent-to-Treat population

The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.

Outcome measures

Measure	Group I - Weekly Celaderm n=13 Participants Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=15 Participants Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=12 Participants Adaptic and Profore four-layer compression dressing
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).	3 participants	7 participants	5 participants

Adverse Events

Group I - Weekly Celaderm

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Group II - Bi-weekly Celaderm

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Group III - Control

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group I - Weekly Celaderm n=13 participants at risk Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=15 participants at risk Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=12 participants at risk Adaptic and Profore four-layer compression dressing
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/13	6.7% 1/15 • Number of events 1	8.3% 1/12 • Number of events 1
Respiratory, thoracic and mediastinal disorders Acute Exacerbation of Chronic Asthma	0.00% 0/13	6.7% 1/15 • Number of events 1	0.00% 0/12
Infections and infestations Urinary Tract Infection	0.00% 0/13	0.00% 0/15	8.3% 1/12 • Number of events 1
Vascular disorders Critical Limb Ischemia	0.00% 0/13	0.00% 0/15	8.3% 1/12 • Number of events 1
Cardiac disorders Chest Pain	0.00% 0/13	0.00% 0/15	8.3% 1/12 • Number of events 1
General disorders Swelling	0.00% 0/13	0.00% 0/15	8.3% 1/12 • Number of events 1
Nervous system disorders Siezure	7.7% 1/13 • Number of events 1	0.00% 0/15	0.00% 0/12

Other adverse events

Measure	Group I - Weekly Celaderm n=13 participants at risk Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group II - Bi-weekly Celaderm n=15 participants at risk Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing	Group III - Control n=12 participants at risk Adaptic and Profore four-layer compression dressing
Infections and infestations Ulcer Infection	23.1% 3/13 • Number of events 4	13.3% 2/15 • Number of events 2	16.7% 2/12 • Number of events 2

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place