Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients

NCT04959071 | Completed DMC

• 1 other identifier: VAC vs Conventional Dressing
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients. DFUs are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Different treatment modalities are available for treating DFUs. Amongst them VAC provides a new paradigm for diabetic wound dressing. Different studies concluded that DFUs treated with VAC are more likely to heal than CD. The average healing time varies greatly among different studies conducted. Therefore, we conducted this study to compare the mean healing time of wound after VAC and CD in DFU patients. Based on these results, the method with lesser healing time can be opted for our routine practice guidelines for DFU patient's management protocol.

Conditions

Diabetic Foot Ulcer; Healing Delayed; Wound; Foot; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Comparison of mean healing time of wounds in diabetic foot ulcers among Vac and conventional dressings

  participants were assessed for mean healing time of wound after VAC theray and conventional dressing. All participants were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . Healing time was measured in number of days. The start time was the application of first VAC and end time will be the day of wound healing (appearance of granulation tissue over wound as assessed clinically). Similarly start time in conventional dressings was from day of first application of conventional dressing till appearance of granulation tissues over the wound. In both groups mean healing time was compared to see any difference in healing time of both the groups.

  1 month

Study Arms (2)

Group A

EXPERIMENTAL

Group A included participants who underwent VAC therapy for diabetic Foot ulcers

Procedure: Vacuum assisted closure VAC vs conventional dressing

Group B

ACTIVE COMPARATOR

Group B included participants who underwent conventional dressings for diabetic foot ulcers

Procedure: Vacuum assisted closure VAC vs conventional dressing

Interventions

Vacuum assisted closure VAC vs conventional dressing PROCEDURE

In participants undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours. In participants with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily.

Also known as: Conventional Dressing

Group A; Group B

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients with diabetic foot ulcer of \>2 weeks duration. 2. Size of ulcer \>3 cm. 3. Well controlled diabetes (HbA1C=6-8.3%). 4. Age 25-65 years. 5. Both genders.

You may not qualify if:

• Anemic patients (hemoglobin \<10 g/dl).
• Patients with history of steroid intake.
• Patients with chronic renal failure (assessed on history and s/creatinine \>1.5 mg/dl).
• Patients with history of immunosuppressive therapy.
• Ulcers involving bone as well.

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Bahria University Medical and Dental College Karachi

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (4)

• Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabet Foot Ankle. 2014 Apr 8;5. doi: 10.3402/dfa.v5.23345. eCollection 2014.

  PMID: 24765245 BACKGROUND

• Ravari H, Modaghegh MH, Kazemzadeh GH, Johari HG, Vatanchi AM, Sangaki A, Shahrodi MV. Comparision of vacuum-asisted closure and moist wound dressing in the treatment of diabetic foot ulcers. J Cutan Aesthet Surg. 2013 Jan;6(1):17-20. doi: 10.4103/0974-2077.110091.

  PMID: 23723599 BACKGROUND

• Lavery LA, Murdoch DP, Kim PJ, Fontaine JL, Thakral G, Davis KE. Negative Pressure Wound Therapy With Low Pressure and Gauze Dressings to Treat Diabetic Foot Wounds. J Diabetes Sci Technol. 2014 Mar;8(2):346-349. doi: 10.1177/1932296813519012. Epub 2014 Feb 18.

  PMID: 24876586 BACKGROUND

• James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.

  PMID: 31007506 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Foot Injuries; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Leg Injuries; Wounds and Injuries; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Surgery at PNS Shifa Hospital Karachi

Model Details: Randomized control trial. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 13, 2021
• Study Start: February 28, 2020
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)