A Phase 4 interventional study of Cefadroxil 500 mg Capsules and Clindamycin in Fracture Lower Leg, Diabetes and Fracture Fixation, Internal, sponsored by Texas Tech University Health Sciences Center, El Paso. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Phase 4, Interventional, and Prevention
Among 3,021 studies in Diabetes Mellitus with a site in United States — 288 open to participants now, 389 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,021 studies in Diabetes Mellitus with a site in United States, this one is the 1,665th largest by planned enrollment of the 2,500 interventional ones that give a count, is one of 96 that started in 2026, is one of 215 in phase 4, reaches primary completion later than 234 of the 381 other live ones, and was the 2,985th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →288 of the 3,021 studies in Diabetes Mellitus with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 14–24
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,021 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 1 262 · Phase 2 371 · Phase 3 340 · Phase 4 215
First in 1976; this study’s year is marked. 96 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Median enrollment 82 across the 2,500 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 987 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
852 of 3,021 have an industry lead sponsor. The 10 most frequent:
Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Texas Tech University Health Sciences Center, El Paso has 4 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Among the 3,021 studies in Diabetes Mellitus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are:
Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course?
Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections.
Participants will:
Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following surgical fixation of a lower extremity fracture effectively decreases the risk of surgical site infection in patients with poorly controlled diabetes. Patients with an uncontrolled hemoglobin A1c greater than 7.0 or a random blood glucose greater than 200 mg/dL undergoing operative fixation of a closed fracture of the distal femur, patella, tibial plateau, tibial shaft, pilon, ankle, talus, calcaneus, or other operative foot fracture are considered high-risk for surgical site infection and are the target population for this study.
Study participants will be randomized to either a 7-day course of an oral prophylactic antibiotic following surgery (cefadroxil 500 mg twice daily, or an alternative regimen based on allergy status or methicillin-resistant Staphylococcus aureus colonization) or standard care with no additional antibiotics beyond the standard perioperative intravenous antibiotic dosing. All other standard perioperative fracture care will remain the same for both groups. Outcomes assessed will include superficial and deep surgical site infection occurring within 90 days of surgery, antibiotic-related adverse effects, and patient compliance with the extended antibiotic regimen.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols.
Extended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy
Drug: Cefadroxil 500 mg Capsules · Drug: Clindamycin · Drug: Bactrim DS
Cefadroxil 500 mg, twice a day for 7 days
Also known as: Duricef
Clindamycin 300 mg, three times a day for 7 days
Bactrim DS, twice a day for 7 days
Surgical site infection
Incidence of superficial infection (a wound with erythema, warmth, or drainage that is treated with oral antibiotics or wound care) and deep infection (per fracture-related infection definition).
Time frame: 90 days
Antibiotic-related adverse effects
Incidence of antibiotic-related adverse effects
Time frame: 90 days
Compliance with antibiotic regimen
Number of patients completing prescribed antibiotic regimen or not
Time frame: 1 week
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Dec 2027, 20 months after the start.
Of 149 non-industry phase 4 interventional studies under Diabetes Mellitus, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 20 months is below that.
Counting every sponsor, half of 197 studies reached it within 24 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Cefadroxil · Clindamycin
Texas Tech University Health Sciences Center, El Paso