Trial · NCT00796744

Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers

NCT00796744, Phase 2, Completed, US Biotest, Inc.; results first posted 2012-09-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers. Trials, record NCT00796744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796744

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
NCT number: NCT00796744
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: US Biotest, Inc.
Conditions: Foot Ulcer, Diabetic, Diabetic Foot
Interventions: NorLeu3-A(1-7) in a gel formulation
First posted: 2008-11-24
Last updated: 2012-09-27
Results first posted: 2012-09-27

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.	Healing to occur within 12 weeks of first treatment
Secondary	The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	Duration of subject's participation (24 weeks)
Secondary	The Rate of Re-epithelialization of the Ulcer Site.	12 weeks	The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.
Secondary	The Time to Re-epithelialization of the Ulcer Site.	24 weeks	Average time to complete re-epithelialization of baseline ulcer area.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.	Healing to occur within 12 weeks of first treatment	Intent-to-Treat Population	number of ulcers healed	NUMBER
SECONDARY	The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	Duration of subject's participation (24 weeks)	Safety Population	patients	NUMBER
SECONDARY	The Rate of Re-epithelialization of the Ulcer Site.	12 weeks		percent ulcer area re-epithelialized/wk	MEAN
SECONDARY	The Time to Re-epithelialization of the Ulcer Site.	24 weeks		Weeks	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.	Placebo		8	15.6 to 55.3	number of ulcers healed
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.	0.03% DSC127		14	33.4 to 73.4	number of ulcers healed
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.	0.01% DSC127		8	13.8 to 50.2	number of ulcers healed
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	Placebo Vehicle Control	All Adverse Event	23		patients
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	0.03 % DSC127	All Adverse Event	26		patients
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	0.01% DSC127	All Adverse Event	28		patients
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	Placebo Vehicle Control	Serious Adverse Event	5		patients
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	0.03 % DSC127	Serious Adverse Event	4		patients
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	0.01% DSC127	Serious Adverse Event	4		patients
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	Placebo Vehicle Control	Related to Study Drug	0		patients

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Vehicle Control	24
Overall Study	STARTED	0.03 % DSC127	26
Overall Study	STARTED	0.01% DSC127	28
Overall Study	COMPLETED	Placebo Vehicle Control	24
Overall Study	COMPLETED	0.03 % DSC127	26
Overall Study	COMPLETED	0.01% DSC127	27
Overall Study	NOT COMPLETED	Placebo Vehicle Control	0
Overall Study	NOT COMPLETED	0.03 % DSC127	0
Overall Study	NOT COMPLETED	0.01% DSC127	1

Source ClinicalTrials.gov

Adverse events81

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Placebo Vehicle Control	0	24	0
other	Constipation	Gastrointestinal disorders	0.03 % DSC127	2	26	2
other	Constipation	Gastrointestinal disorders	0.01% DSC127	1	28	1
other	Nausea	Gastrointestinal disorders	Placebo Vehicle Control	1	24	1
other	Nausea	Gastrointestinal disorders	0.03 % DSC127	2	26	2
other	Nausea	Gastrointestinal disorders	0.01% DSC127	0	28	0
other	Vomiting	Gastrointestinal disorders	Placebo Vehicle Control	2	24	3
other	Vomiting	Gastrointestinal disorders	0.03 % DSC127	0	26	0
other	Vomiting	Gastrointestinal disorders	0.01% DSC127	1	28	1
other	Diabetic foot infection	Infections and infestations	Placebo Vehicle Control	2	24	2

1 to 10 of 81Source ClinicalTrials.gov

See all 81 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Vehicle Control
Total, all-cause mortality	0.03 % DSC127
Total, all-cause mortality	0.01% DSC127
Total, other adverse events	Placebo Vehicle Control	16	24
Total, other adverse events	0.03 % DSC127	15	26
Total, other adverse events	0.01% DSC127	18	28
Total, serious adverse events	Placebo Vehicle Control	5	24
Total, serious adverse events	0.03 % DSC127	4	26
Total, serious adverse events	0.01% DSC127	4	28

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11472620	BACKGROUND	PubMed
12621191	BACKGROUND	PubMed
14714558	BACKGROUND	PubMed
15953051	BACKGROUND	PubMed
22672145	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00796744

GET https://conductscience.org/api/trials/v1/NCT00796744/events?page=2

API reference For AI assistants