Trial Outcomes & Findings for Diabetic Foot Ulcer Study on Topical Interventions (NCT NCT02577900)

NCT ID: NCT02577900

Last Updated: 2019-04-16

Results Overview

The number of participants have absence of a visible wound achieved by complete epithelialization

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	Acticoat Absorbent Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
Overall Study STARTED	11	10	10
Overall Study COMPLETED	11	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Acticoat Absorbent n=11 Participants Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet n=10 Participants Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet n=10 Participants Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval	Total n=31 Participants Total of all reporting groups
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Age, Categorical <=18 years	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=11 Participants	7 Participants n=10 Participants	6 Participants n=10 Participants	19 Participants n=31 Participants
Age, Categorical >=65 years	5 Participants n=11 Participants	3 Participants n=10 Participants	4 Participants n=10 Participants	12 Participants n=31 Participants
Age, Continuous	63.36 years STANDARD_DEVIATION 11.31 • n=11 Participants	65.6 years STANDARD_DEVIATION 11.42 • n=10 Participants	66.1 years STANDARD_DEVIATION 12.31 • n=10 Participants	64.97 years STANDARD_DEVIATION 11.34 • n=31 Participants
Sex: Female, Male Female	4 Participants n=11 Participants	6 Participants n=10 Participants	3 Participants n=10 Participants	13 Participants n=31 Participants
Sex: Female, Male Male	7 Participants n=11 Participants	4 Participants n=10 Participants	7 Participants n=10 Participants	18 Participants n=31 Participants

PRIMARY outcome

Timeframe: 12 weeks

The number of participants have absence of a visible wound achieved by complete epithelialization

Outcome measures

Measure	Acticoat Absorbent n=11 Participants Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet n=10 Participants Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet n=10 Participants Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
Number of Participants With Complete Healing of Ulcer During the Observation Period	9 participants	5 participants	4 participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Acticoat Absorbent n=11 Participants Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet n=10 Participants Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet n=10 Participants Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
Change in Ulcer Size	97.45 percentage of ulcer size changes Standard Deviation 5.98	86.25 percentage of ulcer size changes Standard Deviation 15.98	77.51 percentage of ulcer size changes Standard Deviation 26.40

SECONDARY outcome

Timeframe: Week 1, Week 4

Outcome measures

Measure	Acticoat Absorbent n=11 Participants Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet n=10 Participants Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet n=10 Participants Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4 week 1	3412.38 ng/ ml Standard Deviation 5322.27	5655.76 ng/ ml Standard Deviation 7163.14	5365.84 ng/ ml Standard Deviation 13725.55
the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4 week 4	5720.59 ng/ ml Standard Deviation 10480.71	17672.54 ng/ ml Standard Deviation 11276.75	1987.39 ng/ ml Standard Deviation 2892.48

SECONDARY outcome

Timeframe: Week 1, Week 4

Outcome measures

Measure	Acticoat Absorbent n=11 Participants Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet n=10 Participants Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet n=10 Participants Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4 week 1	9.93 ng/ ml Standard Deviation 6.21	24.89 ng/ ml Standard Deviation 26.76	9.92 ng/ ml Standard Deviation 8.83
the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4 week 4	21.77 ng/ ml Standard Deviation 18.26	12.44 ng/ ml Standard Deviation 9.13	11.03 ng/ ml Standard Deviation 8.51

SECONDARY outcome

Timeframe: Week 1, Week 4

Outcome measures

Measure	Acticoat Absorbent n=11 Participants Apply Acticoat absorbent onto the ulcer Acticoat absorbent: Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval	Honey Gel Sheet n=10 Participants Apply Honey gel sheet onto the ulcer Honey gel sheet: Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval	Jelonet n=10 Participants Apply Jelonet onto the ulcer Jelonet: Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4 week 4	0.57 ng/ ml Standard Deviation 0.96	2.08 ng/ ml Standard Deviation 2.28	2.21 ng/ ml Standard Deviation 2.70
the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4 week 1	1.13 ng/ ml Standard Deviation 1.17	1.93 ng/ ml Standard Deviation 1.32	0.62 ng/ ml Standard Deviation 0.71

Adverse Events

Acticoat Absorbent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Honey Gel Sheet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Jelonet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tsang Ka-Kit

Queen Elizabeth Hospital

Phone: +852-35062610

Email: kktsang3@netvigator.com

Results disclosure agreements

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