N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
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|ClinicalTrials.gov Identifier: NCT03253328|
Recruitment Status : Suspended (No one is currently receiving treatment and enrollment is of course on hold. Subjects being unblinded to perform interim analysis.)
First Posted : August 17, 2017
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Critical Limb Ischemia Lower Limb Amputation Knee Peripheral Arterial Disease||Drug: Active Arm N-acetyl cysteine (NAC) Drug: Placebo Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||N-Acetyl-Cysteine for Healing of Amputation Stumps in the Setting of Diabetes|
|Actual Study Start Date :||December 15, 2016|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: Active Arm N-acetyl cysteine (NAC)
Upon study enrollment, patients will be randomized 1:1 by Investigational Pharmacy to a standard adult intravenous dose of NAC (1200mg twice a day) for 6 days post-amputation.
Drug: Active Arm N-acetyl cysteine (NAC)
N-acetyl cysteine (NAC) 1200mg twice a day for 6 days post-amputation
Other Name: N-acetyl cysteine (NAC)
Placebo Comparator: Placebo Arm
Upon study enrollment, patients will be randomized 1:1 by Investigational Pharmacy to placebo ½ normal saline infusion (twice a day) for 6 days post-amputation.
Drug: Placebo Arm
Placebo 1/2 normal saline infusion twice a day for 6 days post-amputation
Other Name: Placebo 1/2 normal saline infusion
- Stump Healing using the Bates-Jensen Wound Assessment Tool [ Time Frame: 30 days ]A validated scoring algorithm used to determine the degree to which a wound has successfully healed. We will use a modified version of this tool and score the following parameters: amputation stump skin color, epithelialization, amount and type of exudate, and the size and type of necrotic eschar tissue. Each feature was evaluated on a 1 through 5 scoring system, with lower scores indicating best healing, and higher scores indicating poor healing. Participants are given an overall aggregate score, with higher scores indicating poor healing. These measurements are taken at the participant's first clinical follow up appointment.
- Determine effect size to power a larger trial [ Time Frame: 1 year ]Statistical measurement of effect size to power a larger trial.
- Perfusion [ Time Frame: 30 days ]The Primary Study Endpoints will measure if patients who receive peri-operative NAC administrative have lower Bates-Jensen Wound Healing Scores than their non-NAC counterparts.
- Stump Healing [ Time Frame: 5 days ]The Primary Study Endpoints will measure if patients who receive peri-operative NAC administrative have lower Bates-Jensen Wound Healing Scores than their non-NAC counterparts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253328
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Mohamed Zayed, MD||Washington University School of Medicine|