An Early Phase 1 interventional study of Active Arm N-acetyl cysteine (NAC) and Placebo Arm in Diabetes Mellitus, Critical Limb Ischemia and Lower Limb Amputation Knee, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment
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Among 46 studies in Diabetes Mellitus by Washington University School of Medicine — 3 open to participants now, 5 under way, none of them phase 3. Diabetes Mellitus · Washington University School of Medicine.
Among the 46 studies in Diabetes Mellitus by Washington University School of Medicine, this one is the 25th largest by enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2017, is one of 5 in phase 1, and was the 36th registered.
8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.
Browse Diabetes Mellitus studies →3 of the 46 studies in Diabetes Mellitus by Washington University School of Medicine are open now, in 2 countries. Recruiting first, the newest first:
Washington University School of Medicine · Sites in Nigeria
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 0+
Washington University School of Medicine · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 30 Years to 90 Years · all sexes · no healthy volunteers.
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46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 3 · Phase 3 2 · Phase 4 2
First in 1992; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 33 is below the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 58 across the 35 interventional studies, 101 across the 10 observational. Of the 37 that completed or were terminated, 18 (49%) have results posted.
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Washington University School of Medicine is the lead sponsor of 1,804 studies on the registry; 270 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
2 of the studies in Diabetes Mellitus by Washington University School of Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07777900Washington University School of MedicineGlycated Albumin Monitoring | 2027-01-15 |
| NCT02841553Washington University School of MedicineWolfram Syndrome and WFS1-related Disorders International Registry and Clinical Study | 2027-04 |
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Among the 46 studies in Diabetes Mellitus by Washington University School of Medicine, from their registry updates:
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In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity amputation. By exploring the primary endpoints we aim to determine whether NAC can affect amputation stump perfusion and healing. Based on preclinical data, the investigators hypothesize that NAC will augment both amputation stump perfusion as well as healing. The investigators will utilize the data from this trial to determine the true effect size that is necessary for a larger clinical trial to determine the clinical efficacy of NAC is healing surgical sites such as major lower extremity amputation stumps.
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial, in 50 participants with CLI who have undergone a major (above-knee or below-knee) lower extremity amputation. 25 participants will receive NAC 1200mg intravenously twice a day for 6 consecutive days following amputation. 25 participants will receive placebo saline intravenous infusion twice a day for 6 days following amputation. Post-amputation participants will be monitored for specific anthropometric parameters and stump perfusion assessments (using laser-assisted fluorescent angiography and transcutaneous oxygen pressure measurement). The primary study endpoints are to determine if lower extremity stump healing and perfusion are affected by perioperative NAC administration. A secondary endpoint will be to determine the effect size that would be necessary to power a larger clinical trial to determine whether NAC treatment can affect tissue perfusion and healing at major lower extremity amputation stumps in participants with CLI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
N-acetyl cysteine (NAC) 1200mg twice a day for 6 days post-amputation
Also known as: N-acetyl cysteine (NAC)
Placebo 1/2 normal saline infusion twice a day for 6 days post-amputation
Also known as: Placebo 1/2 normal saline infusion
Change in Postoperative Laser-Assisted Fluorescent Angiography (LAFA) Perfusion.
Images were collected from the SPY Elite LAFA apparatus. Regions of interest were drawn in a standardized fashion around either the incision or the whole amputation stump. NIH image J software was used to evaluate peak perfusion signal intensity in all regions of interest. Change in LAFA was assessed at postoperative day (POD) 0, 3, and 5. Fold change in % perfusion in the ROI's between POD 0/3/5 was determined and compared between study groups. The primary outcomes were change in postoperative Laser-Assisted Fluorescent Angiography (LAFA) perfusion at POD3 and POD5 and stump healing at postoperative day 30 (POD30).
Time frame: Day 0, Day 3, Day 5
Stump Healing Assessment at Postoperative Day (POD) 30.
Amputation stump photographs were serially obtained for all study patients immediately before LAFA assessments on POD 0, 3, and 5. A blinded observer evaluated amputation stump incision healing using a modified Bates-Jensen Score (mBJS) wound assessment tool. As previously described, the amputation stumps were evaluated on the following criteria: amputation stump skin color, epithelialization, amount of exudate, and the presence and volume of eschar. Each wound healing characteristic was given a score of 1 to 5, with higher scores indicating worse healing. Eschar volume was determined using ImageJ software. Aggregate mBJS scores were derived for both the whole stump and along the suture line. Clinical amputation stump healing was determined by the surgeon at follow-up clinical evaluations up until POD30. De Silva GS, Saffaf K, Sanchez LA, et al. Amputation stump perfusion is predictive of post-operative necrotic eschar formation. Am J Surg. 2018;216:540-546.
Time frame: 30 days
Amputation Stump Perfusion in High Risk Patients
POD0 LAFA was evaluated for all patients and patients that demonstrated amputation stump peak perfusion defects were considered high risk. Within these patients we then evaluated amputation stump perfusion at POD5. Change in perfusion over this time was compared between the study groups.
Time frame: POD5
Recruited from March 2017 to April 2020. We initially planned to enroll 15 subjects in each group but recruitment was suspended in May 2020 due to COVID-19. Study team leadership determined that unmasking of study randomization would facilitate analysis of primary/secondary endpoints and determine whether data supported overall study hypothesis. After pandemic disruptions were eased interim study analysis was completed and the study closed. No safety concerns led to early termination.
| Milestone | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm |
|---|---|---|
| Started | 16 | 17 |
| Completed | 10 | 16 |
| Not completed | 6 | 1 |
Images were collected from the SPY Elite LAFA apparatus. Regions of interest were drawn in a standardized fashion around either the incision or the whole amputation stump. NIH image J software was used to evaluate peak perfusion signal intensity in all regions of interest. Change in LAFA was assessed at postoperative day (POD) 0, 3, and 5. Fold change in % perfusion in the ROI's between POD 0/3/5 was determined and compared between study groups. The primary outcomes were change in postoperative Laser-Assisted Fluorescent Angiography (LAFA) perfusion at POD3 and POD5 and stump healing at postoperative day 30 (POD30).
| percentage of defect | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm |
|---|---|---|
| POD 0 | 0.060 ± 0.056 | 0.096 ± 0.117 |
| POD 3 | 0.045 ± 0.047 | 0.031 ± 0.055 |
| POD 5 | 0.015 ± 0.026 | 0.050 ± 0.058 |
Amputation stump photographs were serially obtained for all study patients immediately before LAFA assessments on POD 0, 3, and 5. A blinded observer evaluated amputation stump incision healing using a modified Bates-Jensen Score (mBJS) wound assessment tool. As previously described, the amputation stumps were evaluated on the following criteria: amputation stump skin color, epithelialization, amount of exudate, and the presence and volume of eschar. Each wound healing characteristic was given a score of 1 to 5, with higher scores indicating worse healing. Eschar volume was determined using ImageJ software. Aggregate mBJS scores were derived for both the whole stump and along the suture line. Clinical amputation stump healing was determined by the surgeon at follow-up clinical evaluations up until POD30. De Silva GS, Saffaf K, Sanchez LA, et al. Amputation stump perfusion is predictive of post-operative necrotic eschar formation. Am J Surg. 2018;216:540-546.
| Participants | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm |
|---|---|---|
| Overall Number of Participants Analyzed | 10 | 16 |
| Perfusion Defects | 7 | 13 |
| Adequate Perfusion | 3 | 3 |
POD0 LAFA was evaluated for all patients and patients that demonstrated amputation stump peak perfusion defects were considered high risk. Within these patients we then evaluated amputation stump perfusion at POD5. Change in perfusion over this time was compared between the study groups.
| Participants | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm |
|---|---|---|
| Perfusion Defects | 7 | 13 |
| Adequate Perfusion | 3 | 3 |
Collected over Postoperative Day 30 (POD30). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Arm N-acetyl Cysteine (NAC) | 0/16 (0%) | 0/16 (0%) | 6/16 (37.5%) |
| PLACEBO | 0/17 (0%) | 0/17 (0%) | 5/17 (29.4%) |
| Event | Active Arm N-acetyl Cysteine (NAC) | PLACEBO |
|---|---|---|
| Non-healing amputation siteVascular disorders | 1/16 | 0/17 |
| Erosive esophagitisGeneral disorders | 1/16 | 0/17 |
| HypovolemiaBlood and lymphatic system disorders | 1/16 | 0/17 |
| Diabetic ketoacidosis (DKA)Endocrine disorders | 1/16 | 0/17 |
| Amputation stump revision due to a fallGeneral disorders | 1/16 | 0/17 |
| DeathInfections and infestations | 1/16 | 0/17 |
| Conversion from BKA to AKASurgical and medical procedures | 0/16 | 1/17 |
| Stump painVascular disorders | 0/16 | 1/17 |
| Constipation resulting in hospitalizationGastrointestinal disorders | 0/16 | 1/17 |
| Fecal impactionGastrointestinal disorders | 0/16 | 1/17 |
| Age, Continuous(years) | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm | Total |
|---|---|---|---|
| Median | 69 ± 12 | 62 ± 11 | 65.5 ± 11.5 |
| Sex: Female, Male(Participants) | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 10 | 10 | 20 |
| Race and Ethnicity Not Collected(Participants) | Active Arm N-acetyl Cysteine (NAC) | Placebo Arm | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2017 to primary completion in Aug 2021, 53 months.
Results were first posted in Aug 2024, 2 years 11 months after primary completion.
Of 76 non-industry phase 1 interventional studies under Diabetes Mellitus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 55. This study's 53 months is above that.
Counting every sponsor, half of 247 studies reached it within 7 months; a quarter within 3 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetylcysteine
Washington University School of Medicine →